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Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT02606305
Recruitment Status : Completed
First Posted : November 17, 2015
Results First Posted : February 14, 2024
Last Update Posted : February 14, 2024
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Interventions Drug: Mirvetuximab soravtansine
Drug: Bevacizumab
Drug: Carboplatin
Drug: Pegylated Liposomal Doxorubicin
Drug: Pembrolizumab
Enrollment 264
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description Participants were administered mirvetuximab soravtansine 5 milligrams (mg)/kilograms (kg) + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg. Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin area under the time-concentration curve (AUC4) on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + pegylated liposomal doxorubicin (PLD) 30 mg/meter squared (m^2) on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Period Title: Dose Escalation: Regimens A, B, C and D
Started 3 11 0 0 0 4 4 10 4 5 7 4 10 0 0
Received at Least 1 Dose of Study Drug 3 11 0 0 0 4 4 10 4 5 7 4 10 0 0
Completed 3 11 0 0 0 4 4 10 4 5 7 4 10 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Dose Expansion: Regimens A and D
Started 0 0 21 34 60 0 0 0 0 0 0 0 0 46 0
Received at Least 1 Dose of Study Drug 0 0 21 34 60 0 0 0 0 0 0 0 0 0 0
Completed 0 0 21 34 60 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 46 0
Period Title: Triplet Dose: Regimen E
Started 0 0 0 0 0 0 0 0 0 0 0 0 0 0 41
Received at Least 1 Dose of Study Drug 0 0 0 0 0 0 0 0 0 0 0 0 0 0 41
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 41
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin Total
Hide Arm/Group Description Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg. Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 3 11 21 34 60 4 4 10 4 5 7 4 10 46 41 264
Hide Baseline Analysis Population Description
All participants who were enrolled and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 11 participants 21 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants 264 participants
64.3  (11.85) 65.5  (8.43) 62.2  (7.40) 61.4  (9.99) 61.4  (9.87) 59.3  (9.14) 67.0  (7.07) 66.0  (10.33) 59.5  (12.07) 65.2  (4.66) 60.6  (5.35) 58.3  (6.18) 63.5  (10.81) 61.1  (8.64) 63.8  (9.40) 62.3  (9.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 11 participants 21 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants 264 participants
Female
3
 100.0%
11
 100.0%
21
 100.0%
34
 100.0%
60
 100.0%
4
 100.0%
4
 100.0%
10
 100.0%
4
 100.0%
5
 100.0%
7
 100.0%
4
 100.0%
10
 100.0%
46
 100.0%
41
 100.0%
264
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 11 participants 21 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants 264 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
2
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
1
   2.4%
6
   2.3%
Not Hispanic or Latino
3
 100.0%
11
 100.0%
21
 100.0%
32
  94.1%
58
  96.7%
4
 100.0%
4
 100.0%
9
  90.0%
4
 100.0%
4
  80.0%
7
 100.0%
4
 100.0%
10
 100.0%
45
  97.8%
39
  95.1%
255
  96.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
3
   1.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 11 participants 21 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants 264 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.3%
2
   4.9%
7
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
2
   0.8%
White
3
 100.0%
10
  90.9%
21
 100.0%
32
  94.1%
53
  88.3%
4
 100.0%
4
 100.0%
10
 100.0%
4
 100.0%
5
 100.0%
7
 100.0%
4
 100.0%
10
 100.0%
43
  93.5%
39
  95.1%
249
  94.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
3
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   1.5%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Adverse events (AEs) were any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function that developed or worsened during the clinical study, not necessarily having a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes previously listed. TEAEs were any AE that emerged on or after the first dose, and within 30 days of the last dose. Serious and other non-serious AEs regardless of causality are reported in the AE module.
Time Frame From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were enrolled and received at least 1 dose of study drug. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
Arm/Group Title Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 126 4 4 10 4 5 7 4 56 41
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
3
 100.0%
126
 100.0%
4
 100.0%
4
 100.0%
10
 100.0%
4
 100.0%
4
  80.0%
7
 100.0%
4
 100.0%
56
 100.0%
41
 100.0%
SAEs
2
  66.7%
49
  38.9%
2
  50.0%
4
 100.0%
3
  30.0%
1
  25.0%
2
  40.0%
3
  42.9%
2
  50.0%
25
  44.6%
17
  41.5%
Grade >=3 TEAEs
2
  66.7%
85
  67.5%
2
  50.0%
4
 100.0%
7
  70.0%
2
  50.0%
3
  60.0%
6
  85.7%
1
  25.0%
30
  53.6%
37
  90.2%
2.Primary Outcome
Title Dose Expansion (Regimens A and D) and Triplet (Regimen E): Objective Response Rate (ORR); Percentage of Participants With Confirmed Response, as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Hide Description ORR was defined as percentage of participants with confirmed response (complete response [CR] + partial response [PR]). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD. The 95% confidence interval (CI) was based on binomial distribution.
Time Frame From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose.
Arm/Group Title Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 21 34 60 45 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52
(29.78 to 74.29)
29
(15.10 to 47.48)
50
(36.81 to 63.19)
27
(14.60 to 41.94)
83
(67.94 to 92.85)
3.Secondary Outcome
Title Dose Escalation (Regimens A Through D): ORR; Percentage of Participants With Confirmed Response, as Assessed by RECIST Version 1.1
Hide Description ORR was defined as percentage of participants with confirmed response (CR + PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least 30% decrease in the SLD of target lesions, taking as reference the baseline SLD.
Time Frame From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 4 4 9 4 5 7 4 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.00 to 0.00)
45
(16.75 to 76.62)
50
(6.76 to 93.24)
50
(6.76 to 93.24)
89
(51.75 to 99.72)
0
(0.00 to 0.00)
20
(0.51 to 71.64)
29
(3.67 to 70.96)
25
(0.63 to 80.59)
50
(18.71 to 81.29)
4.Secondary Outcome
Title Progression-Free Survival (PFS); Time From the Date Of First Dose Until The Date Of Progressive Disease (PD) Or Death By Any Cause, As Defined By RECIST Version 1.1
Hide Description PFS was defined as the time from the date of the first dose of study drug until the date of PD or death from any cause, whichever occurred first, estimated using the Kaplan-Meier method. PFS was defined based on radiological assessments and determined by the investigator. PD was defined as at least a 20% increase in the SLD of target lesions, taking as reference the smallest (nadir) SLD since and including baseline. In addition to the relative increase of 20%, the SLD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame From first dose of study drug until the date of PD or death by any cause (maximum exposure: 238.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg administered on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 21 34 60 4 4 9 4 5 7 4 10 45 41
Median (95% Confidence Interval)
Unit of Measure: months
13.49 [1] 
(11.76 to NA)
8.80 [1] 
(1.18 to NA)
9.92 [1] 
(7.13 to NA)
6.77
(4.63 to 10.71)
8.28
(6.34 to 11.01)
13.52 [1] 
(10.38 to NA)
32.94 [1] 
(10.38 to NA)
16.46 [1] 
(6.97 to NA)
NA [2] 
(1.68 to NA)
7.03 [1] 
(0.26 to NA)
7.23 [1] 
(1.45 to NA)
2.53 [1] 
(1.18 to NA)
9.46 [1] 
(1.38 to NA)
4.17
(2.79 to 5.52)
13.50
(9.86 to 16.30)
[1]
Due to smaller number of events, upper 95% CI could not be calculated.
[2]
Due to smaller number of events, median and upper 95% CI could not be calculated.
5.Secondary Outcome
Title Duration of Response (DOR) Per RECIST v1.1 by Investigator Assessment
Hide Description DOR was defined as the time from the date of the first response (CR or PR), to the date of PD or death from any cause, whichever occurred first. DOR was only defined for patients who had a best overall response of CR or PR, estimated using the Kaplan-Meier method. The response-evaluable population included all patients with radiographic assessment at baseline, who received at least 1 dose of combination treatment and had at least 1 post-dose radiographic tumor assessment or who died within 105 days of first dose.
Time Frame From the date of first objective response to the time of PD (maximum exposure: 238.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. Only participants who had best overall response of CR or PR were analyzable.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 0 5 11 10 30 2 2 8 0 1 2 1 5 12 34
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(2.76 to NA)
11.96 [2] 
(2.99 to NA)
14.06 [2] 
(3.91 to NA)
10.38
(6.93 to 13.67)
NA [1] 
(6.05 to NA)
31.77 [2] 
(9.20 to NA)
12.12 [2] 
(4.40 to NA)
NA [1] 
(NA to NA)
NA [1] 
(5.29 to NA)
3.42 [3] 
(NA to NA)
8.31 [2] 
(6.93 to NA)
4.37 [2] 
(2.79 to NA)
10.87
(8.71 to 15.15)
[1]
Due to smaller number of events, median and upper 95% CI could not be calculated.
[2]
Due to smaller number of events, upper 95% CI could not be calculated.
[3]
Due to smaller number of events, 95% CI could not be calculated.
6.Secondary Outcome
Title Gynecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 Clinical Response Rate by Investigator Assessment
Hide Description A CA-125 response was defined as a ≥ 50% reduction in CA-125 levels from baseline. GCIG CA125 response rate was defined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100. The CA-125 evaluable population included all participants whose pretreatment sample was ≥2.0 times the upper limit of normal, within 2 weeks prior to the first dose of combination treatment, and who had at least 1 post-baseline CA-125 evaluation.
Time Frame From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
CA125 Evaluable Population: All participants whose pretreatment sample is ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to the first dose of combination treatment, and who have at least 1 post-baseline CA125 evaluation.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 1 10 16 26 56 3 3 7 3 2 6 2 8 37 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(2.5 to 100.0)
60
(26.2 to 87.8)
75
(47.6 to 92.7)
65
(44.3 to 82.8)
71
(57.8 to 82.7)
67
(9.4 to 99.2)
100
(29.2 to 100.0)
86
(42.1 to 99.6)
0 [1] 
(NA to NA)
50
(1.3 to 98.7)
50
(11.8 to 88.2)
0 [1] 
(NA to NA)
63
(24.5 to 91.5)
46
(29.5 to 63.1)
100
(87.2 to 100.0)
[1]
Due to no events, 95% CI could not be calculated.
7.Secondary Outcome
Title Pharmacokinetics (PK) Parameter: Maximum Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total Antibody
Hide Description Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in micrograms/milliliter (µg/mL).
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 34 60 4 4 10 4 5 7 4 10 46 41
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Mirvetuximab Soravtansine: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
135
(9.2%)
137
(14.5%)
159
(30.4%)
159
(17.2%)
150
(17.2%)
118
(15.4%)
108
(15.7%)
144
(19.3%)
115
(21.5%)
114
(15.8%)
146
(16.8%)
112
(4%)
156
(13.2%)
151
(17.4%)
144
(18.5%)
Mirvetuximab Soravtansine: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA%)
148
(15.8%)
164
(12.4%)
174
(14.1%)
137
(144%)
46
(999%)
121
(15.1%)
147
(12.1%)
NA [1] 
(NA%)
137
(15.4%)
142
(6.03%)
114
(20%)
165
(10.6%)
159
(15.7%)
128
(66.1%)
Total Antibody: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
121
(11.8%)
122
(12.9%)
152
(31.1%)
148
(24.2%)
153
(13%)
118
(18.2%)
102
(16.4%)
129
(11.8%)
111
(23.5%)
114
(18.6%)
152
(17.2%)
94.7
(34.2%)
124
(11.8%)
146
(16.4%)
144
(18.3%)
Total Antibody: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 10 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA%)
147
(25.1%)
177
(26.6%)
175
(22.7%)
180
(41%)
57.9
(238%)
122
(20.9%)
149
(15.5%)
NA [1] 
(NA%)
124
(3.32%)
140
(19%)
114
(17.8%)
160
(23%)
165
(17.4%)
146
(44.2%)
[1]
Geometric mean Cmax could not be calculated for n<3
8.Secondary Outcome
Title PK Parameter: Cmax of N2'-[4-[(3-carboxypropyl)Dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-Deacetylmaytansine (DM4) and S-methyl DM4 (SmDM4)
Hide Description Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in nanograms (ng)/mL.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 35 60 4 4 10 4 5 7 4 10 46 41
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
DM4: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 35 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
3.04
(21.8%)
4.71
(32.9%)
5.51
(35.8%)
6.32
(33.8%)
5.59
(37.5%)
2.96
(8.85%)
3.72
(28.7%)
6.4
(27.7%)
4.12
(47.5%)
3.93
(18.3%)
6.58
(86.4%)
4.54
(49.3%)
5.6
(31.2%)
5.27
(35.3%)
4.52
(38.4%)
DM4: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA%)
5.06
(30.5%)
4.57
(27.3%)
6.16
(43.8%)
5.45
(69.1%)
3.06
(23.4%)
3.38
(15%)
5.66
(31.2%)
NA [1] 
(NA%)
5.1
(34.4%)
7.02
(70.8%)
3.91
(5.81%)
4.91
(37.3%)
4.95
(33.3%)
4.44
(25.7%)
S-methyl DM4: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 35 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
3.61
(26.7%)
9.6
(65.5%)
11.5
(61.7%)
12.2
(68.9%)
12.2
(62.6%)
5.75
(56.3%)
7.91
(46.9%)
13
(37.5%)
7.23
(50.8%)
7.51
(58.1%)
11.9
(77.1%)
11.3
(56.6%)
17
(91.8%)
12.8
(63.6%)
8.64
(71.7%)
S-methyl DM4: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA%)
12.3
(71.1%)
11.8
(55.7%)
12.2
(51.9%)
12.5
(89.2%)
3.21
(220%)
6.79
(59.1%)
14.1
(43.9%)
NA [1] 
(NA%)
10.8
(55.7%)
17.6
(63%)
16.2
(11.1%)
18
(52.9%)
13
(71.6%)
9.49
(104%)
[1]
Geometric mean Cmax could not be calculated for n<3
9.Secondary Outcome
Title PK Parameter: Area Under the Time-Concentration Curve From Time 0 To Infinite Time (AUCinf) of Mirvetuximab Soravtansine and Total Antibody
Hide Description Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in mg*hours (h)/mL.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 34 60 4 4 10 4 5 7 4 10 45 41
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg*h/mL
Mirvetuximab Soravtansine: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 4 participants 7 participants 4 participants 10 participants 45 participants 41 participants
16.1
(2.34%)
17
(13.9%)
18.6
(22.2%)
18.4
(22.1%)
17.5
(19.8%)
14.8
(13.8%)
11.3
(23%)
16.3
(26.7%)
14
(23.8%)
15.2
(34.1%)
16.2
(33.1%)
12.1
(19.1%)
17
(30.5%)
16.9
(32.9%)
17.8
(26.3%)
Mirvetuximab Soravtansine: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 53 participants 3 participants 4 participants 8 participants 2 participants 4 participants 7 participants 3 participants 8 participants 40 participants 39 participants
NA [1] 
(NA%)
21.6
(37.2%)
22.7
(14.1%)
22.8
(24.9%)
22.3
(16.7%)
15.2
(22.1%)
17.9
(16.1%)
19.9
(26.5%)
NA [1] 
(NA%)
17.4
(19.4%)
16.4
(14.1%)
14.4
(32.1%)
20.2
(28.2%)
20.9
(30.8%)
19.7
(20%)
Total Antibody: Cycle 1 Number Analyzed 2 participants 7 participants 15 participants 20 participants 50 participants 4 participants 4 participants 9 participants 4 participants 3 participants 6 participants 4 participants 7 participants 31 participants 32 participants
NA [1] 
(NA%)
20.6
(22.2%)
24.5
(31.4%)
23.5
(34.2%)
25.8
(22%)
18
(22.2%)
13.3
(29%)
21.6
(35.1%)
20.1
(55%)
17.8
(73.5%)
24.8
(26.2%)
16.8
(16.3%)
18.4
(49.1%)
20
(44.6%)
25
(25.4%)
Total Antibody: Cycle 3 Number Analyzed 2 participants 4 participants 10 participants 18 participants 28 participants 2 participants 0 participants 3 participants 2 participants 2 participants 6 participants 2 participants 3 participants 20 participants 17 participants
NA [1] 
(NA%)
24.2
(31.3%)
36.1
(23%)
34.7
(49.3%)
39.2
(20.1%)
NA [1] 
(NA%)
30
(26%)
NA [1] 
(NA%)
NA [1] 
(NA%)
29.1
(33.6%)
NA [1] 
(NA%)
20.1
(29.7%)
28.9
(55.2%)
35.8
(32.6%)
[1]
Geometric mean AUCinf could not be calculated for n<3
10.Secondary Outcome
Title PK Parameter: AUCinf of Intact DM4 and SmDM4
Hide Description Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Note that '9999' is used because AUCinf cannot be calculated for n<3.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 2 10 20 32 57 4 4 9 4 4 7 4 10 46 37
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
DM4: Cycle 1 Number Analyzed 2 participants 10 participants 20 participants 29 participants 54 participants 4 participants 4 participants 9 participants 3 participants 4 participants 5 participants 3 participants 10 participants 43 participants 37 participants
NA [1] 
(NA%)
249
(12.6%)
253
(28.2%)
289
(30.9%)
272
(28.4%)
161
(15.2%)
202
(21.6%)
315
(55.6%)
223
(64.8%)
180
(19.7%)
262
(49.6%)
192
(33.2%)
269
(17.7%)
261
(31.6%)
256
(40.7%)
DM4: Cycle 3 Number Analyzed 2 participants 8 participants 15 participants 29 participants 50 participants 3 participants 4 participants 8 participants 1 participants 3 participants 6 participants 3 participants 8 participants 39 participants 36 participants
NA [1] 
(NA%)
282
(14.1%)
263
(31.4%)
315
(36.5%)
285
(27.2%)
146
(22%)
180
(17.4%)
295
(31.3%)
NA [1] 
(NA%)
200
(24.2%)
289
(53.6%)
163
(7.42%)
245
(29.7%)
260
(38.2%)
243
(29.2%)
S-methyl DM4: Cycle 1 Number Analyzed 2 participants 8 participants 19 participants 32 participants 57 participants 3 participants 2 participants 9 participants 4 participants 4 participants 6 participants 4 participants 9 participants 40 participants 35 participants
NA [1] 
(NA%)
1700
(51.5%)
1710
(73.2%)
1980
(60.7%)
2120
(62.1%)
1370
(49.2%)
NA [1] 
(NA%)
2160
(56.5%)
1510
(63.7%)
1660
(119%)
1830
(72.2%)
2050
(50%)
2930
(91.3%)
2460
(70.8%)
1830
(61.2%)
S-methyl DM4: Cycle 3 Number Analyzed 2 participants 10 participants 17 participants 31 participants 50 participants 3 participants 3 participants 8 participants 2 participants 4 participants 7 participants 2 participants 8 participants 38 participants 36 participants
NA [1] 
(NA%)
1730
(76.3%)
1620
(58.5%)
1930
(52.9%)
2120
(57.8%)
1130
(14.3%)
1600
(49.6%)
1600
(52.4%)
NA [1] 
(NA%)
1800
(80.8%)
2290
(70%)
NA [1] 
(NA%)
2280
(61.9%)
2080
(75.5%)
1550
(61.8%)
[1]
Geometric mean AUCinf could not be calculated for n<3
11.Secondary Outcome
Title PK Parameter: Terminal Half-Life (t½) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4
Hide Description

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. PK parameters were calculated using standard non-compartmental methods.

The terminal t½ is an estimate (extrapolation) of the time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half (50%). If extrapolated AUC was greater than 20% (due to insufficient number of participants with data samples) the upper range of t½ was not reported.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (up to 336 hours) (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 34 60 4 4 10 4 4 7 4 10 46 41
Median (Full Range)
Unit of Measure: h
Mirvetuximab Soravtansine: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 4 participants 7 participants 4 participants 10 participants 46 participants 41 participants
104
(104 to 143)
123
(89.5 to 146)
124
(76 to 154)
121
(59.1 to 161)
126
(82.1 to 168)
117
(97.8 to 119)
123
(97.7 to 152)
128
(92.5 to 151)
124
(114 to 176)
148
(67.6 to 187)
137
(86.2 to 156)
120
(115 to 135)
126
(70.3 to 184)
126
(57.5 to 173)
122
(85.9 to 172)
Mirvetuximab Soravtansine: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 54 participants 3 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 40 participants
NA [1] 
(NA to NA)
132
(93.7 to 157)
132
(100 to 178)
128
(65.9 to 181)
130
(84.9 to 199)
124
(119 to 146)
124
(116 to 161)
137
(108 to 165)
NA [1] 
(NA to NA)
175
(76.6 to 237)
119
(103 to 140)
114
(97.8 to 118)
132
(99.9 to 173)
133
(62.5 to 192)
140
(97.6 to 202)
Total Antibody: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 4 participants 7 participants 4 participants 10 participants 46 participants 41 participants
142
(107 to 226)
206
(114 to 330)
182 [2] 
(87.9 to NA)
221 [2] 
(76.2 to NA)
200
(119 to 315)
189
(156 to 225)
170
(165 to 286)
208
(109 to 333)
231
(200 to 299)
282 [2] 
(80.6 to NA)
249
(182 to 314)
184
(168 to 209)
182
(68.9 to 269)
196 [2] 
(58 to NA)
215 [2] 
(111 to NA)
Total Antibody: Cycle 3 Number Analyzed 2 participants 9 participants 18 participants 32 participants 54 participants 3 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA to NA)
235 [2] 
(165 to NA)
214 [2] 
(127 to NA)
228 [2] 
(86.8 to NA)
216 [2] 
(146 to NA)
214 [2] 
(143 to NA)
290 [2] 
(160 to NA)
214 [2] 
(163 to NA)
NA [1] 
(NA to NA)
337 [2] 
(94.5 to NA)
230 [2] 
(88.4 to NA)
197
(135 to 278)
269 [2] 
(170 to NA)
232 [2] 
(70.3 to NA)
252 [2] 
(148 to NA)
DM4: Cycle 1 Number Analyzed 3 participants 10 participants 20 participants 30 participants 55 participants 4 participants 4 participants 9 participants 4 participants 4 participants 5 participants 3 participants 10 participants 45 participants 39 participants
49.9
(40.5 to 121)
74.4
(47.8 to 104)
70.2
(47.2 to 99.7)
61.9
(43.9 to 100)
63.9
(40.1 to 124)
59.4
(45 to 73.3)
60.6
(40.4 to 124)
52.4
(39.6 to 115)
65.9
(48.6 to 120)
55.8
(51.7 to 65.6)
57.4
(43 to 91.4)
46.4
(38 to 62.9)
73.6
(42.8 to 131)
59.4
(29.8 to 219)
57.5
(39.9 to 116)
DM4: Cycle 3 Number Analyzed 2 participants 8 participants 17 participants 30 participants 51 participants 3 participants 4 participants 9 participants 1 participants 3 participants 7 participants 3 participants 8 participants 39 participants 37 participants
NA [1] 
(NA to NA)
83.8
(40.8 to 94.1)
73.9
(32.8 to 102)
71.1
(39.4 to 111)
78.3
(19.1 to 109)
68
(52.3 to 69.6)
63.6
(59 to 111)
74.1
(52.7 to 101)
NA [1] 
(NA to NA)
96
(71.7 to 105)
64.4
(45.5 to 115)
46.5
(41.7 to 65.5)
64.6
(53.3 to 109)
64
(33 to 161)
63
(45.2 to 109)
S-methyl DM4: Cycle 1 Number Analyzed 2 participants 8 participants 20 participants 32 participants 58 participants 3 participants 2 participants 9 participants 4 participants 4 participants 7 participants 4 participants 9 participants 41 participants 38 participants
NA [1] 
(NA to NA)
132
(97 to 178)
126
(97.8 to 245)
129
(81.7 to 217)
139
(94.1 to 209)
128
(96 to 151)
NA [1] 
(NA to NA)
132
(99.2 to 165)
168
(133 to 220)
181
(156 to 285)
154 [2] 
(126 to NA)
132
(106 to 169)
134
(104 to 163)
127
(73.4 to 253)
126
(84.4 to 292)
S-methyl DM4: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 31 participants 50 participants 3 participants 4 participants 10 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 37 participants
NA [1] 
(NA to NA)
128
(97.3 to 216)
132
(94.8 to 172)
126
(86.7 to 207)
121
(79.1 to 196)
140
(127 to 186)
168
(107 to 233)
124
(100 to 155)
NA [1] 
(NA to NA)
182
(165 to 251)
169
(105 to 213)
171
(130 to 192)
148
(120 to 158)
140
(88.3 to 253)
138
(84.9 to 275)
[1]
As per the PK analysis plan, t½ statistics were not calculated when less than 3 individual values were available.
[2]
NA = Insufficient number of participants with events (data samples) for accurate calculation of t½ upper range, therefore, not reported.
12.Secondary Outcome
Title PK Parameter: Clearance (CL) of Mirvetuximab Soravtansine and Total Antibody
Hide Description Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 34 60 4 4 10 4 4 7 4 10 45 41
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/h
Mirvetuximab Soravtansine: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 4 participants 7 participants 4 participants 10 participants 45 participants 41 participants
19.2
(18.8%)
22
(17.2%)
22
(29.1%)
20.9
(23.3%)
23.4
(23.8%)
19.9
(10.1%)
28.9
(17%)
22
(26.1%)
21.2
(22.3%)
23.3
(38.6%)
24.5
(41.3%)
29.2
(17.1%)
23.9
(34.5%)
22.8
(34.5%)
22.1
(26.8%)
Mirvetuximab Soravtansine: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 53 participants 3 participants 4 participants 8 participants 2 participants 4 participants 7 participants 3 participants 8 participants 40 participants 39 participants
NA [1] 
(NA%)
16.9
(34.4%)
17.7
(23%)
16.5
(26.9%)
18.3
(21.4%)
19.3
(17.9%)
18.2
(14%)
17.2
(24.9%)
NA [1] 
(NA%)
20.3
(23.9%)
24.3
(21.4%)
26.4
(25%)
18.3
(36.8%)
17.7
(35.6%)
19.2
(23.6%)
Total Antibody: Cycle 1 Number Analyzed 2 participants 7 participants 15 participants 20 participants 50 participants 4 participants 4 participants 9 participants 4 participants 3 participants 6 participants 4 participants 7 participants 31 participants 32 participants
NA [1] 
(NA%)
18
(23.8%)
17.5
(36.5%)
16.7
(33.9%)
16.3
(25.9%)
16.3
(19.8%)
24.5
(24.6%)
16.6
(36.1%)
14.7
(47.1%)
19.3
(83.4%)
15.7
(34.6%)
21.1
(15.2%)
22.6
(49.2%)
20
(44.7%)
16.1
(26.7%)
Total Antibody: Cycle 3 Number Analyzed 2 participants 4 participants 10 participants 18 participants 28 participants 2 participants 0 participants 3 participants 2 participants 2 participants 6 participants 2 participants 3 participants 20 participants 17 participants
NA [1] 
(NA%)
15
(34.3%)
11.7
(27.3%)
11.2
(43.3%)
10.7
(26%)
NA [1] 
(NA%)
11.1
(20.5%)
NA [1] 
(NA%)
NA [1] 
(NA%)
13.9
(40.5%)
NA [1] 
(NA%)
16.4
(63.9%)
12.9
(57.5%)
9.69
(38.1%)
[1]
Geometric mean CL could not be calculated for n<3
13.Secondary Outcome
Title PK Parameter: CL of DM4 and SmDM4
Hide Description Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 2 10 20 32 57 4 4 9 4 4 7 4 10 43 37
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
DM4: Cycle 1 Number Analyzed 2 participants 10 participants 20 participants 29 participants 54 participants 4 participants 4 participants 9 participants 3 participants 4 participants 5 participants 3 participants 10 participants 43 participants 37 participants
NA [1] 
(NA%)
29
(19.3%)
30.9
(31.5%)
25.2
(36.6%)
28.6
(33.3%)
35
(14.6%)
30.7
(26.8%)
21.8
(64.7%)
25.1
(59.3%)
37.4
(28.3%)
28.2
(52.2%)
35.5
(57.2%)
28.8
(30.7%)
27.7
(27.5%)
29.1
(40.4%)
DM4: Cycle 3 Number Analyzed 2 participants 8 participants 15 participants 29 participants 50 participants 3 participants 4 participants 8 participants 1 participants 3 participants 6 participants 3 participants 8 participants 39 participants 36 participants
NA [1] 
(NA%)
23.5
(26.4%)
28.9
(33%)
22.7
(39.7%)
27.2
(35.5%)
38.6
(16%)
34.5
(23.4%)
22.1
(45.8%)
NA [1] 
(NA%)
33.5
(41.5%)
26.6
(54.3%)
44.6
(22.3%)
28.8
(44.4%)
26.7
(31.8%)
29.5
(31.5%)
S-methyl DM4: Cycle 1 Number Analyzed 2 participants 8 participants 19 participants 32 participants 57 participants 3 participants 2 participants 9 participants 4 participants 4 participants 6 participants 4 participants 9 participants 40 participants 35 participants
NA [1] 
(NA%)
4.49
(40.2%)
4.77
(61.1%)
3.84
(57.9%)
3.82
(60.8%)
4.39
(52%)
NA [1] 
(NA%)
3.35
(70.6%)
3.9
(59.6%)
4.21
(119%)
4.17
(62.8%)
3.42
(73%)
2.78
(91.8%)
3.06
(63.2%)
4.25
(57.1%)
S-methyl DM4: Cycle 3 Number Analyzed 2 participants 10 participants 17 participants 31 participants 50 participants 3 participants 3 participants 8 participants 2 participants 4 participants 7 participants 2 participants 8 participants 38 participants 36 participants
NA [1] 
(NA%)
4.18
(66.4%)
4.97
(48.6%)
3.84
(50.5%)
3.87
(52.7%)
5.19
(20.3%)
4.19
(48.3%)
4.26
(59%)
NA [1] 
(NA%)
3.9
(83.4%)
3.45
(56.3%)
NA [1] 
(NA%)
3.22
(81.9%)
3.57
(63.9%)
4.78
(60.4%)
[1]
Geometric mean CL could not be calculated for n<3
14.Secondary Outcome
Title PK Parameter: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4
Hide Description Blood samples from participants were analyzed to characterize PK when administered in 3- or 4-week cycles.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 34 60 4 4 10 4 5 7 4 10 45 41
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
Mirvetuximab Soravtansine Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 34 participants 60 participants 4 participants 4 participants 10 participants 4 participants 4 participants 7 participants 4 participants 10 participants 45 participants 41 participants
2.93
(18.2%)
3.63
(12.4%)
3.54
(19.7%)
3.31
(18.5%)
3.87
(25.2%)
3.23
(7.04%)
4.29
(11.9%)
3.52
(23.3%)
3.69
(17.9%)
3.8
(10.7%)
3.88
(24.1%)
4.58
(20.9%)
3.78
(21.8%)
3.59
(23.1%)
3.73
(23%)
Mirvetuximab Soravtansine Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 53 participants 3 participants 4 participants 8 participants 2 participants 4 participants 7 participants 3 participants 8 participants 40 participants 39 participants
NA [1] 
(NA%)
3.21
(14.1%)
3.25
(13.2%)
2.83
(23.3%)
3.23
(23.4%)
3.37
(13.3%)
3.4
(15.7%)
3.13
(12.5%)
NA [1] 
(NA%)
3.78
(16.6%)
3.98
(19%)
3.94
(15.4%)
3.28
(31%)
3.1
(25.8%)
3.51
(21.6%)
Total Antibody Cycle 1 Number Analyzed 2 participants 7 participants 15 participants 20 participants 50 participants 4 participants 4 participants 9 participants 4 participants 3 participants 6 participants 4 participants 7 participants 31 participants 32 participants
NA [1] 
(NA%)
4.38
(16.1%)
4.05
(22.7%)
3.9
(34.9%)
4.06
(23.9%)
4.03
(28.1%)
5.67
(10.7%)
4.27
(24.4%)
4.48
(39.2%)
5.01
(1.58%)
4.09
(17.2%)
5.33
(18.7%)
4.69
(23%)
4.09
(30.1%)
4.21
(25.6%)
Total Antibody Cycle 3 Number Analyzed 2 participants 4 participants 10 participants 18 participants 28 participants 2 participants 0 participants 3 participants 2 participants 2 participants 6 participants 2 participants 3 participants 20 participants 17 participants
NA [1] 
(NA%)
3.74
(23.7%)
3.17
(17.2%)
2.97
(34.6%)
2.95
(24.4%)
NA [1] 
(NA%)
3.09
(8.55%)
NA [1] 
(NA%)
NA [1] 
(NA%)
3.76
(49.6%)
NA [1] 
(NA%)
4.01
(57.5%)
3.28
(30.5%)
2.9
(25.4%)
DM4 Cycle 1 Number Analyzed 2 participants 10 participants 20 participants 29 participants 54 participants 4 participants 4 participants 9 participants 3 participants 4 participants 5 participants 3 participants 10 participants 43 participants 37 participants
NA [1] 
(NA%)
2590
(23.8%)
2490
(31.4%)
2010
(38.6%)
2240
(40.4%)
2670
(20.9%)
2580
(59.4%)
1720
(36%)
1880
(51.6%)
2730
(26.5%)
2010
(53.5%)
2100
(80.9%)
2410
(52.5%)
2060
(31.1%)
2350
(45.1%)
DM4 Cycle 3 Number Analyzed 2 participants 8 participants 15 participants 29 participants 50 participants 3 participants 4 participants 8 participants 1 participants 3 participants 6 participants 3 participants 8 participants 39 participants 36 participants
NA [1] 
(NA%)
2190
(20.7%)
2480
(24.3%)
1990
(43.7%)
2370
(35.9%)
3030
(7.84%)
3160
(7.05%)
1900
(55.6%)
NA [1] 
(NA%)
3300
(38.4%)
2140
(35.9%)
2930
(22.9%)
2450
(53.6%)
2270
(32.8%)
2450
(29.1%)
SmDM4 Cycle 1 Number Analyzed 2 participants 8 participants 19 participants 32 participants 57 participants 3 participants 2 participants 9 participants 4 participants 4 participants 6 participants 4 participants 9 participants 40 participants 35 participants
NA [1] 
(NA%)
911
(57.3%)
900
(67.1%)
731
(69.3%)
751
(66.7%)
932
(63.7%)
NA [1] 
(NA%)
652
(65%)
832
(61.6%)
1100
(114%)
855
(66.3%)
695
(81.2%)
547
(97.6%)
592
(66.4%)
840
(65.1%)
SmDM4 Cycle 3 Number Analyzed 2 participants 10 participants 17 participants 31 participants 50 participants 3 participants 3 participants 8 participants 2 participants 4 participants 7 participants 2 participants 8 participants 38 participants 36 participants
NA [1] 
(NA%)
761
(53.6%)
878
(48.6%)
698
(51.8%)
696
(51%)
1100
(1.87%)
833
(24.5%)
754
(60.7%)
NA [1] 
(NA%)
947
(82.5%)
773
(64.7%)
NA [1] 
(NA%)
621
(76.2%)
709
(59.1%)
891
(67.2%)
[1]
Geometric mean Vss could not be calculated for n<3
15.Secondary Outcome
Title PK Parameter: Time to Reach Cmax (Tmax) of Mirvetuximab Soravtansine, Total Antibody, DM4, and SmDM4
Hide Description

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

PK parameters were derived using non-compartmental PK analysis.
Time Frame Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (up to 336 hours) (additionally at Day 22 for Regimen C)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 35 60 4 4 10 4 5 7 4 10 46 41
Median (Full Range)
Unit of Measure: h
Mirvetuximab Soravtansine: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 35 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
1.75
(1.52 to 1.85)
1.9
(1.32 to 7.48)
2.1
(1.63 to 7.8)
1.92
(1.62 to 8.08)
2.06
(1.42 to 24)
1.68
(1.63 to 1.72)
1.96
(1.72 to 7.78)
1.86
(1.5 to 7.57)
4.28
(1.22 to 7.62)
1.73
(1.45 to 7.08)
5.98
(1.73 to 8.05)
2
(1.67 to 7.57)
2.14
(1.87 to 7.72)
2.12
(1.62 to 8.23)
2.07
(1.47 to 8.22)
Mirvetuximab Soravtansine: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA to NA)
3.88 [2] 
(0.967 to NA)
3.46
(1.17 to 7.5)
2.24
(1.02 to 7.37)
1.49 [2] 
(1.08 to NA)
4.06 [2] 
(0.95 to NA)
1.02
(0.95 to 5.35)
1.48
(1.07 to 5.97)
NA [1] 
(NA to NA)
4.04
(1.2 to 7)
6.08
(1.15 to 7.33)
1.45
(1.17 to 22)
1.26
(1.15 to 7.1)
1.5
(0.95 to 25.6)
6.98 [2] 
(0.95 to NA)
Total Antibody: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 35 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
1.75
(1.52 to 5.52)
1.9
(1.32 to 7.75)
2.1
(1.63 to 25.6)
1.9
(1.62 to 48.2)
2.05
(1.48 to 9)
1.68
(1.63 to 24.1)
4.09
(1.72 to 7.78)
1.88
(1.5 to 7.55)
3.84
(1.63 to 6.75)
1.87
(1.45 to 7.53)
5.98
(1.67 to 25)
4.82
(1.67 to 7.87)
2.25
(1.88 to 48.9)
2.08
(1.43 to 8.05)
2.2 [2] 
(1.13 to NA)
Total Antibody: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA to NA)
3.88
(0.967 to 48.9)
3.68
(1.08 to 25.2)
2.24
(1.02 to 27.2)
1.49 [2] 
(1.08 to NA)
6.91 [2] 
(1.02 to NA)
1.03
(0.95 to 7.05)
1.48
(1.17 to 5.83)
NA [1] 
(NA to NA)
1.23
(1.05 to 6.83)
7.12
(6.08 to 49.6)
7.1
(1.05 to 48.7)
3.7
(1.15 to 24)
1.63
(0.95 to 25.1)
3.03 [2] 
(0.967 to NA)
DM4: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 35 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
7.2
(5.52 to 7.27)
7.5
(1.32 to 26.4)
7.78
(1.83 to 8.58)
7.63
(0 to 22.4)
7.58
(1.67 to 24)
7.4
(1.72 to 7.6)
7.56
(6 to 7.78)
7.34
(5.87 to 21.5)
7.12
(5.87 to 7.62)
7.32
(6 to 7.53)
5.98
(1.67 to 8.05)
7.62
(7.53 to 7.87)
7.7
(2.25 to 8.22)
7.58
(1.73 to 24)
7.67
(1.58 to 8.22)
DM4: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA to NA)
7
(1.25 to 7.75)
7.06
(1.25 to 7.63)
6.94
(1.08 to 7.82)
6.96 [2] 
(1.1 to NA)
6.99 [2] 
(6.82 to NA)
6.96
(5.35 to 7.05)
6.08
(5.03 to 7.77)
NA [1] 
(NA to NA)
6.89
(1.2 to 7)
7.02
(6.08 to 7.33)
7.1
(1.05 to 7.6)
7.08
(1.33 to 7.45)
7.03
(0.95 to 24.8)
7.13 [2] 
(0.95 to NA)
S-methyl DM4: Cycle 1 Number Analyzed 3 participants 11 participants 20 participants 35 participants 60 participants 4 participants 4 participants 10 participants 4 participants 5 participants 7 participants 4 participants 10 participants 46 participants 41 participants
23.8
(7.2 to 119)
23.9
(5.87 to 170)
7.83
(5.87 to 46.7)
7.83
(5.68 to 166)
8.26
(6.05 to 170)
48.2
(24.6 to 169)
108
(25.4 to 170)
7.34
(5.87 to 163)
23.8
(6.75 to 23.9)
23.8
(7.53 to 24.4)
7.7
(5.98 to 50.4)
7.72
(7.53 to 49.6)
7.84
(6.17 to 167)
8
(7.18 to 171)
8.15
(6.93 to 167)
S-methyl DM4: Cycle 3 Number Analyzed 2 participants 10 participants 18 participants 32 participants 58 participants 4 participants 4 participants 9 participants 2 participants 4 participants 7 participants 3 participants 8 participants 41 participants 41 participants
NA [1] 
(NA to NA)
7.01
(5.83 to 24.6)
7.17
(5.83 to 47.7)
7.11
(5.67 to 48.7)
7.41 [2] 
(6.02 to NA)
6.99 [2] 
(6.82 to NA)
15.1
(5.35 to 47.6)
6.08
(5.03 to 21.3)
NA [1] 
(NA to NA)
7.04
(6.83 to 47.2)
7.02
(6.08 to 7.33)
7.1
(6.87 to 7.6)
7.08
(6.08 to 7.45)
7.12
(0.95 to 47.3)
7.22 [2] 
(0.95 to NA)
[1]
As per the PK analysis plan, Tmax statistics were not calculated when less than 3 individual values were available.
[2]
NA = Insufficient number of participants with events (data samples) for accurate calculation of Tmax upper range, therefore, not reported.
16.Secondary Outcome
Title Plasma Concentration of Bevacizumab
Hide Description Blood samples from participants at the end of infusion were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.
Time Frame At end of infusion (EOI) of Cycle 1; and at pre-infusion and EOI of Cycles 2 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated Regimen A Dose Expansion Cohort 3: Pt-agnostic: Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.
Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 3 11 20 33 59 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Cycle 1 EOI Number Analyzed 3 participants 11 participants 20 participants 33 participants 59 participants 38 participants
368
(20.2%)
352
(31.9%)
406
(22.3%)
430
(19.3%)
448
(23.2%)
413
(23.9%)
Cycle 2 Pre-infusion Number Analyzed 3 participants 11 participants 19 participants 32 participants 59 participants 39 participants
69.3
(37%)
66
(35.4%)
90.6
(57.8%)
87.5
(37.4%)
88.1
(35%)
92.5
(39.9%)
Cycle 2 EOI Number Analyzed 3 participants 8 participants 20 participants 31 participants 54 participants 39 participants
NA [1] 
(NA%)
477
(23.8%)
429
(38.2%)
528
(20.8%)
559
(28.4%)
473
(44.6%)
Cycle 3 Pre-infusion Number Analyzed 2 participants 9 participants 18 participants 31 participants 54 participants 37 participants
NA [1] 
(NA%)
79.9
(52.9%)
132
(17%)
117
(39.3%)
118
(51.2%)
127
(45.8%)
Cycle 3 EOI Number Analyzed 2 participants 10 participants 16 participants 31 participants 51 participants 38 participants
NA [1] 
(NA%)
408
(59.2%)
540
(23.6%)
556
(17.8%)
616
(22.1%)
531
(33.1%)
Cycle 4 Pre-infusion Number Analyzed 2 participants 8 participants 17 participants 28 participants 51 participants 38 participants
NA [1] 
(NA%)
133
(24.1%)
134
(51.1%)
141
(49.4%)
123
(78.2%)
132
(92.9%)
Cycle 4 EOI Number Analyzed 2 participants 10 participants 17 participants 30 participants 46 participants 40 participants
NA [1] 
(NA%)
537
(25.2%)
539
(20.7%)
505
(39.1%)
584
(35.7%)
485
(128%)
Cycle 5 Pre-infusion Number Analyzed 2 participants 5 participants 16 participants 25 participants 44 participants 37 participants
NA [1] 
(NA%)
134
(18.3%)
163
(28.9%)
151
(36.1%)
137
(61%)
153
(51%)
Cycle 5 EOI Number Analyzed 2 participants 6 participants 16 participants 25 participants 43 participants 37 participants
NA [1] 
(NA%)
583
(31.1%)
565
(19.1%)
587
(20.3%)
558
(80.6%)
547
(24.1%)
Cycle 6 Pre-infusion Number Analyzed 2 participants 5 participants 12 participants 24 participants 41 participants 39 participants
NA [1] 
(NA%)
80.7
(96.8%)
191
(27.6%)
149
(37.8%)
166
(29.6%)
170
(51.5%)
Cycle 6 EOI Number Analyzed 1 participants 7 participants 12 participants 23 participants 38 participants 38 participants
NA [1] 
(NA%)
513
(29.1%)
574
(26.2%)
559
(23.9%)
654
(24.6%)
525
(39.8%)
[1]
Geometric mean plasma concentration could not be calculated for n<3
17.Secondary Outcome
Title Plasma Concentration of Carboplatin
Hide Description Blood samples from participants at the end of infusion were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.
Time Frame At end of infusion, 6 and 24 hours post-infusion of Cycle 1; and at pre-infusion and end of infusion of Cycles 2, 4, 5 and 6; at pre-infusion, end of infusion and 6 and 24 hours post-infusion of Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 4 4 9 41
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cycle 1: EOI Number Analyzed 4 participants 4 participants 9 participants 37 participants
10300
(11.3%)
1060
(35.2%)
13900
(19%)
11800
(25.6%)
Cycle 1: 6 hours post-infusion Number Analyzed 4 participants 4 participants 9 participants 0 participants
2890
(45.6%)
3790
(10.3%)
3120
(151%)
Cycle 1 24 hours post-infusion Number Analyzed 3 participants 4 participants 9 participants 36 participants
719
(4.77%)
913
(19.7%)
1030
(43.8%)
817
(35%)
Cycle 2: Pre-infusion Number Analyzed 4 participants 3 participants 6 participants 38 participants
124
(14.8%)
142
(21.7%)
158
(13.5%)
170
(79.2%)
Cycle 2: EOI Number Analyzed 3 participants 4 participants 9 participants 40 participants
10800
(22%)
11600
(18.5%)
11700
(80.9%)
11000
(146%)
Cycle 3: Pre-infusion Number Analyzed 2 participants 3 participants 6 participants 40 participants
NA [1] 
(NA%)
245
(34.6%)
173
(35.9%)
203
(28.2%)
Cycle 3: EOI Number Analyzed 2 participants 4 participants 8 participants 41 participants
NA [1] 
(NA%)
4170
(946%)
12100
(28.9%)
12300
(26.9%)
Cycle 3: 6 hours post-infusion Number Analyzed 3 participants 4 participants 8 participants 0 participants
1140
(412%)
3890
(29.9%)
1630
(238%)
Cycle 3: 24 hours post-infusion Number Analyzed 2 participants 4 participants 7 participants 35 participants
NA [1] 
(NA%)
1330
(27.3%)
1270
(41.3%)
1440
(49%)
Cycle 4: Pre-infusion Number Analyzed 3 participants 3 participants 6 participants 36 participants
220
(31.8%)
243
(59.1%)
214
(20.6%)
250
(39.9%)
Cycle 4: EOI Number Analyzed 3 participants 2 participants 8 participants 38 participants
8230
(43.9%)
NA [1] 
(NA%)
214
(20.6%)
12500
(29.9%)
Cycle 5: Pre-infusion Number Analyzed 3 participants 2 participants 6 participants 35 participants
199
(41.8%)
NA [1] 
(NA%)
194
(37.9%)
270
(43%)
Cycle 5: EOI Number Analyzed 3 participants 2 participants 8 participants 36 participants
10900
(36.9%)
NA [1] 
(NA%)
13800
(31.8%)
11200
(88.1%)
Cycle 6: Pre-infusion Number Analyzed 3 participants 2 participants 8 participants 37 participants
251
(20.2%)
NA [1] 
(NA%)
234
(24.6%)
271
(45.4%)
Cycle 6: EOI Number Analyzed 3 participants 2 participants 8 participants 35 participants
12100
(32.5%)
NA [1] 
(NA%)
12100
(32.1%)
10700
(77.9%)
[1]
Geometric mean plasma concentration could not be calculated for n<3
18.Secondary Outcome
Title Plasma Concentration of Pegylated Liposomal Doxorubicin
Hide Description Blood samples from participants at the end of infusion were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.
Time Frame At end of infusion of Cycle 1; and at pre-infusion and end of infusion of Cycles 2 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.
Arm/Group Title Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2
Hide Arm/Group Description:
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle.
Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 administered on Day 1 of each 28-day cycle.
Overall Number of Participants Analyzed 4 5 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cycle 1: EOI Number Analyzed 4 participants 5 participants 5 participants
18700
(8.72%)
24400
(14.3%)
26400
(7.85%)
Cycle 2: Pre-infusion Number Analyzed 0 participants 1 participants 5 participants
NA [1] 
(NA%)
226
(44.9%)
Cycle 2: EOI Number Analyzed 4 participants 3 participants 7 participants
17300
(17.1%)
25700
(6.88%)
26100
(12.1%)
Cycle 3: Pre-infusion Number Analyzed 1 participants 4 participants 5 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
228
(63%)
Cycle 3: EOI Number Analyzed 2 participants 4 participants 7 participants
NA [1] 
(NA%)
26200
(12.8%)
26200
(14.3%)
Cycle 4: Pre-infusion Number Analyzed 0 participants 1 participants 5 participants
NA [1] 
(NA%)
151
(54.2%)
Cycle 4: EOI Number Analyzed 2 participants 3 participants 7 participants
NA [1] 
(NA%)
24300
(24.1%)
24400
(15.4%)
Cycle 5: Pre-infusion Number Analyzed 0 participants 1 participants 5 participants
NA [1] 
(NA%)
177
(81.1%)
Cycle 5: EOI Number Analyzed 2 participants 4 participants 7 participants
NA [1] 
(NA%)
23700
(17.1%)
25000
(11.3%)
Cycle 6: Pre-infusion Number Analyzed 0 participants 1 participants 5 participants
NA [1] 
(NA%)
157
(134%)
Cycle 6: EOI Number Analyzed 1 participants 3 participants 7 participants
NA [1] 
(NA%)
22900
(13.3%)
24600
(14.7%)
[1]
Geometric mean plasma concentration could not be calculated for n<3
19.Secondary Outcome
Title Immunogenicity: Number of Participants With Anti-Drug Antibody (ADA) Response to Mirvetuximab Soravtansine
Hide Description Blood samples were collected to measure the presence of ADAs for mirvetuximab soravtansine. Seronegative is defined as a participant that tests negative at all visits. Treatment-emergent ADA is defined as a participant that is seronegative prior to dosing on Day 1 of Cycle 1 and tests positive in both screening and confirmatory assays at one or more subsequent visits. Treatment-unaffected ADA is defined as a participant test positive in both screening and confirmatory assays prior to dosing on Day 1 of Cycle 1 with a post-dose titer increase of less than or equal to 4-fold (based on a 2-fold sample dilution). Treatment-boosted ADA is defined as a participant test positive in both screening and confirmatory assays prior to dosing on Day 1 of Cycle 1 with a post-dose titer increase of more than a 4-fold increase (based on a 2-fold sample dilution).
Time Frame From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 283.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity population included all participants who received at least 1 dose of study drug and have evaluable immunogenicity data. As per analysis plan, all regimens (arms/groups) were combined for each phase of the study (dose escalation and dose expansion) for analysis of ADA.
Arm/Group Title Dose Escalation Phase Dose Expansion Phase
Hide Arm/Group Description:
All participants who received mirvetuximab soravtansine during the dose escalation phase of the study (Regimens A, B, C, and D).
All participants who received mirvetuximab soravtansine during the dose expansion phase of the study (Regimens A, D, and E).
Overall Number of Participants Analyzed 62 202
Measure Type: Count of Participants
Unit of Measure: Participants
Seronegative
51
  82.3%
175
  86.6%
Treatment-emergent ADA
3
   4.8%
11
   5.4%
Treatment-unaffected ADA
7
  11.3%
11
   5.4%
Treatment-boosted ADA
1
   1.6%
5
   2.5%
Time Frame From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks)
Adverse Event Reporting Description Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.
 
Arm/Group Title Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Hide Arm/Group Description Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases. Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m^2 on Day 1 of each 28-day cycle. Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle. All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases. Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.
All-Cause Mortality
Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   5/126 (3.97%)   0/4 (0.00%)   0/4 (0.00%)   0/10 (0.00%)   0/4 (0.00%)   0/5 (0.00%)   0/7 (0.00%)   0/4 (0.00%)   4/56 (7.14%)   2/41 (4.88%) 
Hide Serious Adverse Events
Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   49/126 (38.89%)   2/4 (50.00%)   4/4 (100.00%)   3/10 (30.00%)   1/4 (25.00%)   2/5 (40.00%)   3/7 (42.86%)   2/4 (50.00%)   25/56 (44.64%)   17/41 (41.46%) 
Blood and lymphatic system disorders                       
Anaemia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Febrile neutropenia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Thrombocytopenia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Cardiac disorders                       
Myocardial infarction † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Supraventricular tachycardia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders                       
Small intestinal obstruction † 1  1/3 (33.33%)  7/126 (5.56%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  1/4 (25.00%)  0/5 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  5/56 (8.93%)  2/41 (4.88%) 
Diarrhoea † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  2/41 (4.88%) 
Colitis † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Gastrointestinal haemorrhage † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Abdominal pain † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Rectal haemorrhage † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Duodenal ulcer haemorrhage † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Enterocolitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastric varices † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Intestinal perforation † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nausea † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  0/41 (0.00%) 
Oesophageal haemorrhage † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ascites † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Colonic fistula † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Constipation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Enteritis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Haematemesis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Intestinal obstruction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Large intestinal obstruction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Large intestine perforation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Malignant gastrointestinal obstruction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/56 (0.00%)  0/41 (0.00%) 
Oesophagitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pancreatitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Small intestinal perforation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Varices oesophageal † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vomiting † 1  1/3 (33.33%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  3/56 (5.36%)  1/41 (2.44%) 
General disorders                       
General physical health deterioration † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  0/41 (0.00%) 
Asthenia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Discomfort † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Malaise † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pyrexia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Influenza like illness † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Hepatobiliary disorders                       
Hyperbilirubinaemia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Immune system disorders                       
Anaphylactic reaction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Infections and infestations                       
Sepsis † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Urinary tract infection † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Peritonitis bacterial † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pneumonia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Bronchitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Abdominal abscess † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Clostridium difficile colitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Clostridium difficile infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Device related infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Encephalitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Enterocolitis infectious † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Urosepsis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Injury, poisoning and procedural complications                       
Accidental overdose † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Compression fracture † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hip fracture † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Infusion related reaction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Overdose † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Investigations                       
Alanine aminotransferase increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Aspartate aminotransferase increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Blood creatinine increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Metabolism and nutrition disorders                       
Diabetes mellitus † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Failure to thrive † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Dehydration † 1  0/3 (0.00%)  0/126 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Flank pain † 1  0/3 (0.00%)  0/126 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Chloroma † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nervous system disorders                       
Headache † 1  1/3 (33.33%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Altered state of consciousness † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Cognitive disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Encephalopathy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Haemorrhage intracranial † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Product Issues                       
Device malfunction † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Psychiatric disorders                       
Confusional state † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Renal and urinary disorders                       
Acute kidney injury † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
IgA nephropathy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Urinary retention † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Reproductive system and breast disorders                       
Vaginal haemorrhage † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Pneumonitis † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  3/4 (75.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  4/56 (7.14%)  1/41 (2.44%) 
Dyspnoea † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Epistaxis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pleural effusion † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Acute respiratory failure † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Hypoxia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Pleurisy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Pulmonary embolism † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Respiratory distress † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Skin and subcutaneous tissue disorders                       
Paraneoplastic dermatomyositis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vascular disorders                       
Hypotension † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hypertension † 1  1/3 (33.33%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg Mirvetuximab Soravtansine + Bevacizumab + Carboplatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   125/126 (99.21%)   4/4 (100.00%)   4/4 (100.00%)   10/10 (100.00%)   4/4 (100.00%)   4/5 (80.00%)   7/7 (100.00%)   4/4 (100.00%)   56/56 (100.00%)   41/41 (100.00%) 
Blood and lymphatic system disorders                       
Thrombocytopenia † 1  0/3 (0.00%)  37/126 (29.37%)  2/4 (50.00%)  3/4 (75.00%)  6/10 (60.00%)  0/4 (0.00%)  1/5 (20.00%)  2/7 (28.57%)  0/4 (0.00%)  4/56 (7.14%)  29/41 (70.73%) 
Neutropenia † 1  0/3 (0.00%)  23/126 (18.25%)  1/4 (25.00%)  2/4 (50.00%)  7/10 (70.00%)  0/4 (0.00%)  3/5 (60.00%)  2/7 (28.57%)  0/4 (0.00%)  1/56 (1.79%)  21/41 (51.22%) 
Anaemia † 1  0/3 (0.00%)  11/126 (8.73%)  0/4 (0.00%)  2/4 (50.00%)  5/10 (50.00%)  2/4 (50.00%)  0/5 (0.00%)  3/7 (42.86%)  1/4 (25.00%)  9/56 (16.07%)  13/41 (31.71%) 
Leukopenia † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/56 (1.79%)  7/41 (17.07%) 
Febrile neutropenia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Lymphopenia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Increased tendency to bruise † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Leukocytosis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Iron deficiency anaemia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Lymphadenopathy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Cardiac disorders                       
Palpitations † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  3/41 (7.32%) 
Tachycardia † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  1/56 (1.79%)  2/41 (4.88%) 
Sinus tachycardia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Sinus bradycardia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Angina pectoris † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Atrial fibrillation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Cardiac failure † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Mitral valve disease † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Restrictive cardiomyopathy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Tricuspid valve disease † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ear and labyrinth disorders                       
Ear discomfort † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  4/56 (7.14%)  1/41 (2.44%) 
Tinnitus † 1  0/3 (0.00%)  4/126 (3.17%)  1/4 (25.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Ear pain † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  3/41 (7.32%) 
Deafness † 1  0/3 (0.00%)  1/126 (0.79%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  4/41 (9.76%) 
Hypoacusis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Motion sickness † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vertigo † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  3/41 (7.32%) 
Cerumen impaction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Deafness bilateral † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Ear congestion † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Ear pruritus † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Eustachian tube dysfunction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Middle ear effusion † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Ototoxicity † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Acquired corneal dystrophy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Meibomian gland dysfunction † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Endocrine disorders                       
Hypothyroidism † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  5/56 (8.93%)  0/41 (0.00%) 
Adrenal insufficiency † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Cushingoid † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Hyperthyroidism † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Thyroiditis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Eye disorders                       
Vision blurred † 1  2/3 (66.67%)  71/126 (56.35%)  3/4 (75.00%)  3/4 (75.00%)  6/10 (60.00%)  0/4 (0.00%)  3/5 (60.00%)  3/7 (42.86%)  2/4 (50.00%)  26/56 (46.43%)  31/41 (75.61%) 
Dry eye † 1  1/3 (33.33%)  39/126 (30.95%)  0/4 (0.00%)  1/4 (25.00%)  4/10 (40.00%)  0/4 (0.00%)  1/5 (20.00%)  2/7 (28.57%)  1/4 (25.00%)  20/56 (35.71%)  16/41 (39.02%) 
Keratopathy † 1  0/3 (0.00%)  37/126 (29.37%)  1/4 (25.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  10/56 (17.86%)  20/41 (48.78%) 
Cataract † 1  1/3 (33.33%)  25/126 (19.84%)  1/4 (25.00%)  0/4 (0.00%)  2/10 (20.00%)  0/4 (0.00%)  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%)  6/56 (10.71%)  11/41 (26.83%) 
Visual acuity reduced † 1  0/3 (0.00%)  18/126 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  8/41 (19.51%) 
Photophobia † 1  0/3 (0.00%)  16/126 (12.70%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  2/56 (3.57%)  5/41 (12.20%) 
Eye pain † 1  0/3 (0.00%)  13/126 (10.32%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  9/56 (16.07%)  7/41 (17.07%) 
Corneal cyst † 1  0/3 (0.00%)  8/126 (6.35%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  4/56 (7.14%)  2/41 (4.88%) 
Diplopia † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Eye irritation † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  4/41 (9.76%) 
Foreign body sensation in eyes † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Keratitis † 1  1/3 (33.33%)  4/126 (3.17%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  3/56 (5.36%)  0/41 (0.00%) 
Vitreous floaters † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  2/56 (3.57%)  4/41 (9.76%) 
Corneal deposits † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Visual impairment † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  1/56 (1.79%)  0/41 (0.00%) 
Eye pruritus † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  4/56 (7.14%)  0/41 (0.00%) 
Glaucoma † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Ocular discomfort † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Angle closure glaucoma † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Aphakia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Astigmatism † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Corneal epithelium defect † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Corneal toxicity † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Eye allergy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Eye haemorrhage † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Glare † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Lacrimation increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Meibomian gland dysfunction † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ocular hyperaemia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Optic atrophy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Optic disc drusen † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Pinguecula † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pterygium † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Punctate keratitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Uveitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vitreous opacities † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Acquired corneal dystrophy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Blepharitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Blepharospasm † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Blindness transient † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Conjunctival haemorrhage † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Conjunctival hyperaemia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Corneal epithelial microcysts † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Eye discharge † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Eye swelling † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Lenticular opacities † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Maculopathy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Meibomianitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Myopia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Orbital oedema † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Photopsia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Posterior capsule opacification † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Retinal drusen † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Trichiasis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Vitreous detachment † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastrointestinal disorders                       
Diarrhoea † 1  1/3 (33.33%)  85/126 (67.46%)  4/4 (100.00%)  3/4 (75.00%)  5/10 (50.00%)  3/4 (75.00%)  4/5 (80.00%)  4/7 (57.14%)  2/4 (50.00%)  32/56 (57.14%)  34/41 (82.93%) 
Nausea † 1  2/3 (66.67%)  73/126 (57.94%)  1/4 (25.00%)  2/4 (50.00%)  10/10 (100.00%)  1/4 (25.00%)  4/5 (80.00%)  6/7 (85.71%)  3/4 (75.00%)  30/56 (53.57%)  33/41 (80.49%) 
Vomiting † 1  2/3 (66.67%)  45/126 (35.71%)  2/4 (50.00%)  1/4 (25.00%)  6/10 (60.00%)  1/4 (25.00%)  3/5 (60.00%)  3/7 (42.86%)  2/4 (50.00%)  20/56 (35.71%)  21/41 (51.22%) 
Abdominal pain † 1  1/3 (33.33%)  44/126 (34.92%)  0/4 (0.00%)  0/4 (0.00%)  2/10 (20.00%)  1/4 (25.00%)  2/5 (40.00%)  2/7 (28.57%)  0/4 (0.00%)  18/56 (32.14%)  23/41 (56.10%) 
Abdominal distension † 1  1/3 (33.33%)  33/126 (26.19%)  1/4 (25.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  1/5 (20.00%)  1/7 (14.29%)  0/4 (0.00%)  9/56 (16.07%)  10/41 (24.39%) 
Constipation † 1  1/3 (33.33%)  33/126 (26.19%)  0/4 (0.00%)  1/4 (25.00%)  4/10 (40.00%)  2/4 (50.00%)  4/5 (80.00%)  2/7 (28.57%)  2/4 (50.00%)  16/56 (28.57%)  12/41 (29.27%) 
Abdominal pain upper † 1  0/3 (0.00%)  18/126 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  9/56 (16.07%)  6/41 (14.63%) 
Dyspepsia † 1  0/3 (0.00%)  14/126 (11.11%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  1/7 (14.29%)  0/4 (0.00%)  8/56 (14.29%)  3/41 (7.32%) 
Dry mouth † 1  0/3 (0.00%)  13/126 (10.32%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  8/56 (14.29%)  5/41 (12.20%) 
Stomatitis † 1  1/3 (33.33%)  12/126 (9.52%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  4/7 (57.14%)  0/4 (0.00%)  3/56 (5.36%)  7/41 (17.07%) 
Ascites † 1  0/3 (0.00%)  10/126 (7.94%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  7/56 (12.50%)  3/41 (7.32%) 
Gastrooesophageal reflux disease † 1  0/3 (0.00%)  6/126 (4.76%)  0/4 (0.00%)  2/4 (50.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  6/56 (10.71%)  6/41 (14.63%) 
Colitis † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Flatulence † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  1/56 (1.79%)  1/41 (2.44%) 
Gingival bleeding † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  3/41 (7.32%) 
Abdominal discomfort † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  2/41 (4.88%) 
Rectal haemorrhage † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  4/41 (9.76%) 
Abdominal pain lower † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  1/41 (2.44%) 
Faeces soft † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Frequent bowel movements † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Gingival pain † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Haemorrhoids † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Toothache † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Enteritis † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Haematochezia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Haemorrhoidal haemorrhage † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  3/41 (7.32%) 
Hyperaesthesia teeth † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Small intestinal obstruction † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Abdominal hernia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Abdominal tenderness † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Anal haemorrhage † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Anal incontinence † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Anorectal discomfort † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Aphthous ulcer † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Duodenal ulcer perforation † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Dyschezia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Dysphagia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  3/41 (7.32%) 
Epigastric discomfort † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Faeces discoloured † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Faeces hard † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastric ulcer † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastritis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastrointestinal haemorrhage † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastrointestinal mucosa hyperaemia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gingival recession † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Glossodynia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Hiatus hernia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Intestinal obstruction † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Large intestinal ulcer † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Lip pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Mouth ulceration † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Oesophageal pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Oesophagitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Rectal discharge † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Rectal fissure † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tongue discolouration † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tongue ulceration † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Umbilical hernia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Varices oesophageal † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Anal fissure † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Colonic fistula † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Defaecation urgency † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Dental caries † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  3/41 (7.32%) 
Enterocolitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastrointestinal angiectasia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Hypoaesthesia oral † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Lip dry † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Melaena † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Mouth haemorrhage † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Noninfective gingivitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Oral mucosal hypertrophy † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Oral pain † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Proctalgia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Retching † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Salivary duct inflammation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Teeth brittle † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Tooth loss † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Odynophagia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
General disorders                       
Fatigue † 1  1/3 (33.33%)  67/126 (53.17%)  2/4 (50.00%)  2/4 (50.00%)  7/10 (70.00%)  1/4 (25.00%)  4/5 (80.00%)  4/7 (57.14%)  4/4 (100.00%)  28/56 (50.00%)  30/41 (73.17%) 
Asthenia † 1  0/3 (0.00%)  24/126 (19.05%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  3/56 (5.36%)  4/41 (9.76%) 
Pyrexia † 1  0/3 (0.00%)  18/126 (14.29%)  2/4 (50.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  1/5 (20.00%)  2/7 (28.57%)  1/4 (25.00%)  5/56 (8.93%)  4/41 (9.76%) 
Early satiety † 1  0/3 (0.00%)  12/126 (9.52%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Oedema peripheral † 1  0/3 (0.00%)  11/126 (8.73%)  1/4 (25.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  1/7 (14.29%)  0/4 (0.00%)  6/56 (10.71%)  7/41 (17.07%) 
Chills † 1  0/3 (0.00%)  9/126 (7.14%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  2/56 (3.57%)  2/41 (4.88%) 
Non-cardiac chest pain † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  1/41 (2.44%) 
Pain † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  1/56 (1.79%)  2/41 (4.88%) 
Catheter site pain † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Chest discomfort † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Gait disturbance † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Influenza like illness † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Mucosal inflammation † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Peripheral swelling † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  3/41 (7.32%) 
Administration site extravasation † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Axillary pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site bruise † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site discolouration † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site erythema † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site haemorrhage † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site injury † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site mass † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site pruritus † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site swelling † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Chest pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Extravasation † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Face oedema † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
General physical health deterioration † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Generalised oedema † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Implant site dehiscence † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Localised oedema † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Malaise † 1  0/3 (0.00%)  1/126 (0.79%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  5/56 (8.93%)  3/41 (7.32%) 
Pelvic mass † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Sense of oppression † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Thirst † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site rash † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Catheter site thrombosis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Cyst † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Feeling cold † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Feeling hot † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Injection site bruising † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Medical device site pain † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Oedema † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/56 (0.00%)  0/41 (0.00%) 
Physical deconditioning † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Secretion discharge † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Temperature intolerance † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Vaccination site erythema † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vaccination site oedema † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vaccination site pain † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Hepatobiliary disorders                       
Hyperbilirubinaemia † 1  0/3 (0.00%)  10/126 (7.94%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/56 (1.79%)  4/41 (9.76%) 
Autoimmune hepatitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Biliary colic † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hepatic cirrhosis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nodular regenerative hyperplasia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Bile duct stone † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Cholelithiasis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Hepatic pain † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Liver disorder † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Portal hypertension † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Immune system disorders                       
Contrast media reaction † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Seasonal allergy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  4/41 (9.76%) 
Drug hypersensitivity † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  4/41 (9.76%) 
Infections and infestations                       
Urinary tract infection † 1  1/3 (33.33%)  29/126 (23.02%)  1/4 (25.00%)  0/4 (0.00%)  2/10 (20.00%)  2/4 (50.00%)  2/5 (40.00%)  2/7 (28.57%)  0/4 (0.00%)  9/56 (16.07%)  12/41 (29.27%) 
Nasopharyngitis † 1  0/3 (0.00%)  13/126 (10.32%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  2/56 (3.57%)  4/41 (9.76%) 
Sinusitis † 1  0/3 (0.00%)  9/126 (7.14%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  4/41 (9.76%) 
Upper respiratory tract infection † 1  0/3 (0.00%)  9/126 (7.14%)  1/4 (25.00%)  1/4 (25.00%)  3/10 (30.00%)  0/4 (0.00%)  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%)  5/56 (8.93%)  4/41 (9.76%) 
Pneumonia † 1  0/3 (0.00%)  6/126 (4.76%)  1/4 (25.00%)  1/4 (25.00%)  3/10 (30.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  4/56 (7.14%)  1/41 (2.44%) 
Oral herpes † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gingivitis † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Herpes zoster † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Rhinitis † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Bronchitis † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Catheter site infection † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Conjunctivitis † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Herpes simplex † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Otitis media † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pharyngitis † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tooth abscess † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Abscess † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Abscess jaw † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Bacteraemia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Candida infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Clitoris abscess † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Diverticulitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ear infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Eye infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Gastroenteritis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Genital herpes † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hepatitis A † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hepatitis viral † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Localised infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nail bed infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Osteomyelitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Paronychia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Periodontitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pyuria † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Respiratory tract infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Stoma site abscess † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tooth infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vulvovaginal mycotic infection † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Abdominal abscess † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Cellulitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Chronic sinusitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Conjunctivitis viral † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Corneal infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Cystitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  3/41 (7.32%) 
Escherichia bacteraemia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Fungal infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Fungal skin infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Herpes ophthalmic † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Hordeolum † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Influenza † 1  0/3 (0.00%)  0/126 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Keratitis viral † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Klebsiella infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Laryngitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Nail infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  2/10 (20.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ophthalmic herpes simplex † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Oral candidiasis † 1  0/3 (0.00%)  0/126 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Papilloma viral infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Parotitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Peritonitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Pulpitis dental † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Rash pustular † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Sepsis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Skin infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Staphylococcal infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Vaginal infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Viral infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Viral upper respiratory tract infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Wound infection † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Injury, poisoning and procedural complications                       
Contusion † 1  0/3 (0.00%)  7/126 (5.56%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  6/41 (14.63%) 
Fall † 1  2/3 (66.67%)  7/126 (5.56%)  1/4 (25.00%)  2/4 (50.00%)  1/10 (10.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  7/41 (17.07%) 
Infusion related reaction † 1  0/3 (0.00%)  4/126 (3.17%)  2/4 (50.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/56 (1.79%)  3/41 (7.32%) 
Ligament sprain † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Skin laceration † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Cataract operation complication † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Compression fracture † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Corneal abrasion † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Foot fracture † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Muscle strain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Procedural pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Spinal compression fracture † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Spinal fracture † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tendon injury † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Transfusion reaction † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Wound complication † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Arthropod bite † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Burns first degree † 1  0/3 (0.00%)  0/126 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Eye contusion † 1  1/3 (33.33%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Face injury † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Humerus fracture † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Incisional hernia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/56 (0.00%)  0/41 (0.00%) 
Post procedural contusion † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Post procedural inflammation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Skin abrasion † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Upper limb fracture † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Investigations                       
Aspartate aminotransferase increased † 1  0/3 (0.00%)  34/126 (26.98%)  0/4 (0.00%)  2/4 (50.00%)  3/10 (30.00%)  0/4 (0.00%)  2/5 (40.00%)  3/7 (42.86%)  0/4 (0.00%)  21/56 (37.50%)  13/41 (31.71%) 
Weight decreased † 1  1/3 (33.33%)  32/126 (25.40%)  0/4 (0.00%)  0/4 (0.00%)  2/10 (20.00%)  1/4 (25.00%)  1/5 (20.00%)  3/7 (42.86%)  0/4 (0.00%)  8/56 (14.29%)  11/41 (26.83%) 
Alanine aminotransferase increased † 1  0/3 (0.00%)  31/126 (24.60%)  0/4 (0.00%)  2/4 (50.00%)  3/10 (30.00%)  0/4 (0.00%)  1/5 (20.00%)  3/7 (42.86%)  0/4 (0.00%)  19/56 (33.93%)  10/41 (24.39%) 
Blood alkaline phosphatase increased † 1  0/3 (0.00%)  13/126 (10.32%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  2/7 (28.57%)  0/4 (0.00%)  7/56 (12.50%)  2/41 (4.88%) 
Blood creatinine increased † 1  0/3 (0.00%)  3/126 (2.38%)  1/4 (25.00%)  2/4 (50.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  6/56 (10.71%)  0/41 (0.00%) 
Gamma-glutamyltransferase increased † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  3/56 (5.36%)  2/41 (4.88%) 
Activated partial thromboplastin time prolonged † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Albumin urine present † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Weight increased † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Alanine aminotransferase decreased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ammonia increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Aspartate aminotransferase decreased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Blood creatine increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Blood lactate dehydrogenase increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Blood pressure increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Cardiac murmur † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Electrocardiogram QT prolonged † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Protein urine present † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Transaminases increased † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Bacterial test † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Blood albumin decreased † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Blood potassium increased † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Body temperature increased † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
International normalised ratio increased † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Intraocular pressure increased † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Lipase increased † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Urine output decreased † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Metabolism and nutrition disorders                       
Decreased appetite † 1  1/3 (33.33%)  47/126 (37.30%)  0/4 (0.00%)  3/4 (75.00%)  3/10 (30.00%)  0/4 (0.00%)  0/5 (0.00%)  3/7 (42.86%)  2/4 (50.00%)  15/56 (26.79%)  18/41 (43.90%) 
Hypomagnesaemia † 1  1/3 (33.33%)  27/126 (21.43%)  4/4 (100.00%)  1/4 (25.00%)  2/10 (20.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  6/56 (10.71%)  9/41 (21.95%) 
Dehydration † 1  1/3 (33.33%)  21/126 (16.67%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  10/41 (24.39%) 
Hypokalaemia † 1  0/3 (0.00%)  13/126 (10.32%)  3/4 (75.00%)  2/4 (50.00%)  3/10 (30.00%)  2/4 (50.00%)  0/5 (0.00%)  3/7 (42.86%)  1/4 (25.00%)  12/56 (21.43%)  4/41 (9.76%) 
Hyponatraemia † 1  0/3 (0.00%)  8/126 (6.35%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  3/56 (5.36%)  3/41 (7.32%) 
Hyperglycaemia † 1  0/3 (0.00%)  7/126 (5.56%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Hypercalcaemia † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hyperkalaemia † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Hypophosphataemia † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Hypoalbuminaemia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  2/41 (4.88%) 
Hypoglycaemia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Glucose tolerance impaired † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hyperlipidaemia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Iron deficiency † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Polydipsia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Type 2 diabetes mellitus † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Diabetes mellitus † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Hypernatraemia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Hyperuricaemia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hypocalcaemia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  4/56 (7.14%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Arthralgia † 1  1/3 (33.33%)  26/126 (20.63%)  1/4 (25.00%)  1/4 (25.00%)  3/10 (30.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  12/56 (21.43%)  14/41 (34.15%) 
Myalgia † 1  0/3 (0.00%)  24/126 (19.05%)  0/4 (0.00%)  0/4 (0.00%)  5/10 (50.00%)  0/4 (0.00%)  1/5 (20.00%)  1/7 (14.29%)  0/4 (0.00%)  13/56 (23.21%)  11/41 (26.83%) 
Back pain † 1  0/3 (0.00%)  20/126 (15.87%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  9/56 (16.07%)  8/41 (19.51%) 
Pain in extremity † 1  0/3 (0.00%)  17/126 (13.49%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  6/56 (10.71%)  7/41 (17.07%) 
Muscular weakness † 1  0/3 (0.00%)  16/126 (12.70%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  3/41 (7.32%) 
Muscle spasms † 1  0/3 (0.00%)  13/126 (10.32%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  6/56 (10.71%)  7/41 (17.07%) 
Groin pain † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Neck pain † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  2/41 (4.88%) 
Arthritis † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Flank pain † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Bone pain † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Bursitis † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Exostosis † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Joint stiffness † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Joint swelling † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Limb discomfort † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Musculoskeletal stiffness † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Arthropathy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Coccydynia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Costochondritis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Enthesopathy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Fibromyalgia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Intervertebral disc compression † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Muscle atrophy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Osteoarthritis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pain in jaw † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Periarthritis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Spinal osteoarthritis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tendon disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Enthesophyte † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Muscle discomfort † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Plantar fasciitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Spondylitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tendonitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Basal cell carcinoma † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Benign neoplasm of skin † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Haemangioma of skin † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Seborrhoeic keratosis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Nervous system disorders                       
Headache † 1  1/3 (33.33%)  43/126 (34.13%)  1/4 (25.00%)  1/4 (25.00%)  3/10 (30.00%)  0/4 (0.00%)  3/5 (60.00%)  2/7 (28.57%)  0/4 (0.00%)  12/56 (21.43%)  23/41 (56.10%) 
Neuropathy peripheral † 1  1/3 (33.33%)  33/126 (26.19%)  0/4 (0.00%)  2/4 (50.00%)  0/10 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  1/7 (14.29%)  0/4 (0.00%)  15/56 (26.79%)  14/41 (34.15%) 
Dysgeusia † 1  0/3 (0.00%)  17/126 (13.49%)  0/4 (0.00%)  0/4 (0.00%)  2/10 (20.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  5/56 (8.93%)  8/41 (19.51%) 
Dizziness † 1  0/3 (0.00%)  15/126 (11.90%)  1/4 (25.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%)  8/56 (14.29%)  7/41 (17.07%) 
Peripheral sensory neuropathy † 1  1/3 (33.33%)  14/126 (11.11%)  0/4 (0.00%)  1/4 (25.00%)  6/10 (60.00%)  0/4 (0.00%)  0/5 (0.00%)  2/7 (28.57%)  2/4 (50.00%)  15/56 (26.79%)  7/41 (17.07%) 
Neurotoxicity † 1  0/3 (0.00%)  9/126 (7.14%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Tremor † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Paraesthesia † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Cognitive disorder † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hypoaesthesia † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Taste disorder † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Amnesia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Burning sensation † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Dizziness postural † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Restless legs syndrome † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Sciatica † 1  0/3 (0.00%)  2/126 (1.59%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Balance disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Carpal tunnel syndrome † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Dysaesthesia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Dysgraphia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Encephalopathy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hypogeusia † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Lethargy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Memory impairment † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Migraine with aura † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Peripheral motor neuropathy † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Resting tremor † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Syncope † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Dyskinesia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Essential tremor † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Facial spasm † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Loss of consciousness † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Migraine † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Neuralgia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  0/41 (0.00%) 
Presyncope † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Somnolence † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Product Issues                       
Device occlusion † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Device dislocation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Psychiatric disorders                       
Insomnia † 1  1/3 (33.33%)  18/126 (14.29%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  2/4 (50.00%)  10/56 (17.86%)  6/41 (14.63%) 
Anxiety † 1  0/3 (0.00%)  8/126 (6.35%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  3/56 (5.36%)  7/41 (17.07%) 
Confusional state † 1  0/3 (0.00%)  6/126 (4.76%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Depression † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  5/41 (12.20%) 
Agitation † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Depressed mood † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Disorientation † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Irritability † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nightmare † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Post-traumatic stress disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Seasonal affective disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Sleep disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Hallucination † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Renal and urinary disorders                       
Proteinuria † 1  0/3 (0.00%)  17/126 (13.49%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  5/41 (12.20%) 
Dysuria † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  3/41 (7.32%) 
Pollakiuria † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  3/41 (7.32%) 
Micturition urgency † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  3/41 (7.32%) 
Haematuria † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  2/56 (3.57%)  2/41 (4.88%) 
Urinary incontinence † 1  0/3 (0.00%)  2/126 (1.59%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Acute kidney injury † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Bladder discomfort † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Micturition disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nephritis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Renal colic † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Urinary retention † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Urinary tract pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Bladder pain † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Bladder spasm † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Chromaturia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Leukocyturia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Renal pain † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Stress urinary incontinence † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ureterolithiasis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Urge incontinence † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Reproductive system and breast disorders                       
Pelvic pain † 1  0/3 (0.00%)  7/126 (5.56%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Vaginal haemorrhage † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Breast pain † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vaginal discharge † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Breast cyst † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vulva cyst † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vulval haematoma † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vulvovaginal dryness † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vulvovaginal inflammation † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Vulvovaginal pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Dyspareunia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vaginal prolapse † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vulvovaginal pruritus † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Cough † 1  0/3 (0.00%)  32/126 (25.40%)  1/4 (25.00%)  2/4 (50.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  2/7 (28.57%)  0/4 (0.00%)  14/56 (25.00%)  12/41 (29.27%) 
Dysphonia † 1  0/3 (0.00%)  29/126 (23.02%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  3/56 (5.36%)  9/41 (21.95%) 
Dyspnoea † 1  1/3 (33.33%)  25/126 (19.84%)  1/4 (25.00%)  3/4 (75.00%)  4/10 (40.00%)  0/4 (0.00%)  2/5 (40.00%)  3/7 (42.86%)  0/4 (0.00%)  12/56 (21.43%)  12/41 (29.27%) 
Epistaxis † 1  0/3 (0.00%)  24/126 (19.05%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  9/41 (21.95%) 
Pneumonitis † 1  0/3 (0.00%)  18/126 (14.29%)  1/4 (25.00%)  2/4 (50.00%)  2/10 (20.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  11/56 (19.64%)  8/41 (19.51%) 
Nasal congestion † 1  0/3 (0.00%)  12/126 (9.52%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  5/41 (12.20%) 
Oropharyngeal pain † 1  1/3 (33.33%)  12/126 (9.52%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  4/56 (7.14%)  5/41 (12.20%) 
Rhinorrhoea † 1  0/3 (0.00%)  8/126 (6.35%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Pleural effusion † 1  0/3 (0.00%)  6/126 (4.76%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/7 (28.57%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Upper-airway cough syndrome † 1  0/3 (0.00%)  6/126 (4.76%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  5/41 (12.20%) 
Dyspnoea exertional † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  4/56 (7.14%)  3/41 (7.32%) 
Productive cough † 1  0/3 (0.00%)  4/126 (3.17%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  2/41 (4.88%) 
Hypoxia † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pulmonary embolism † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  2/41 (4.88%) 
Sinus congestion † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  1/56 (1.79%)  0/41 (0.00%) 
Throat irritation † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Aspiration † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Bronchial wall thickening † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Hyperventilation † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Increased viscosity of bronchial secretion † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Interstitial lung disease † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Lung disorder † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nasal discomfort † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Oropharyngeal blistering † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pleuritic pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pulmonary oedema † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Rales † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Rhinitis allergic † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Sinus pain † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Wheezing † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Dry throat † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Haemoptysis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Laryngeal inflammation † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Lung opacity † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Nasal disorder † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nasal dryness † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Paranasal sinus hypersecretion † 1  0/3 (0.00%)  0/126 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pulmonary congestion † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Rhinalgia † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Skin and subcutaneous tissue disorders                       
Erythema † 1  0/3 (0.00%)  11/126 (8.73%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Rash † 1  1/3 (33.33%)  10/126 (7.94%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  3/41 (7.32%) 
Dry skin † 1  0/3 (0.00%)  5/126 (3.97%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  3/56 (5.36%)  2/41 (4.88%) 
Hyperhidrosis † 1  0/3 (0.00%)  4/126 (3.17%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Alopecia † 1  0/3 (0.00%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  1/7 (14.29%)  0/4 (0.00%)  2/56 (3.57%)  1/41 (2.44%) 
Rash maculo-papular † 1  1/3 (33.33%)  3/126 (2.38%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%)  2/56 (3.57%)  2/41 (4.88%) 
Dermatitis acneiform † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Petechiae † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pruritus † 1  0/3 (0.00%)  2/126 (1.59%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  4/56 (7.14%)  4/41 (9.76%) 
Acne † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Acquired porokeratosis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Blister † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Butterfly rash † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Chronic pigmented purpura † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Decubitus ulcer † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Dermatitis bullous † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Dermatitis contact † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Drug eruption † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Ecchymosis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Nail discolouration † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Night sweats † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Palmar erythema † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Perioral dermatitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Photosensitivity reaction † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Rosacea † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Seborrhoeic dermatitis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Skin hyperpigmentation † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Spider naevus † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Urticaria † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Dermal cyst † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  1/41 (2.44%) 
Dermatitis allergic † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Eczema asteatotic † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Nail bed disorder † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Neurodermatitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Onychoclasis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Onychomadesis † 1  1/3 (33.33%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Pain of skin † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  3/5 (60.00%)  2/7 (28.57%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Papule † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Rash macular † 1  1/3 (33.33%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Rash papular † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Rash vesicular † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Skin fissures † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Skin fragility † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Skin haemorrhage † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Skin induration † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Skin lesion † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Rash erythematous † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Social circumstances                       
Corrective lens user † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
Surgical and medical procedures                       
Intraocular lens implant † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vascular disorders                       
Hypertension † 1  0/3 (0.00%)  41/126 (32.54%)  0/4 (0.00%)  1/4 (25.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  4/56 (7.14%)  15/41 (36.59%) 
Flushing † 1  0/3 (0.00%)  13/126 (10.32%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  5/56 (8.93%)  4/41 (9.76%) 
Hot flush † 1  0/3 (0.00%)  6/126 (4.76%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  4/56 (7.14%)  0/41 (0.00%) 
Hypotension † 1  0/3 (0.00%)  5/126 (3.97%)  1/4 (25.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Deep vein thrombosis † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/56 (0.00%)  2/41 (4.88%) 
Lymphoedema † 1  0/3 (0.00%)  1/126 (0.79%)  0/4 (0.00%)  1/4 (25.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  4/41 (9.76%) 
Embolism † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Pelvic venous thrombosis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/56 (1.79%)  0/41 (0.00%) 
Peripheral coldness † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Phlebitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/10 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  1/41 (2.44%) 
Vasculitis † 1  0/3 (0.00%)  0/126 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/10 (10.00%)  0/4 (0.00%)  0/5 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  0/56 (0.00%)  0/41 (0.00%) 
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CMO, ImmunoGen
Organization: ImmunoGen, Inc
Phone: 781-895-0600
EMail: clinicaltrials@immunogen.com
Layout table for additonal information
Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02606305    
Other Study ID Numbers: IMGN853-0402
KEYNOTE PN409 ( Other Identifier: Merck )
First Submitted: November 6, 2015
First Posted: November 17, 2015
Results First Submitted: June 12, 2023
Results First Posted: February 14, 2024
Last Update Posted: February 14, 2024