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A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473743
Recruitment Status : Active, not recruiting
First Posted : March 22, 2018
Results First Posted : October 25, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urothelial Carcinoma
Interventions Drug: Erdafitinib
Drug: Cetrelimab
Drug: Cisplatin
Drug: Carboplatin
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Hide Arm/Group Description Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Period Title: Overall Study
Started 4 3 11 12 3 3 44 45
Treated (Treated Analysis Set) 4 3 11 12 3 3 43 44
Completed 4 3 5 3 2 2 21 17
Not Completed 0 0 6 9 1 1 23 28
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             3
Other             0             0             0             1             0             0             0             0
Ongoing             0             0             6             8             1             1             22             24
Randomized but not treated             0             0             0             0             0             0             1             1
Arm/Group Title Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg Total
Hide Arm/Group Description Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Total of all reporting groups
Overall Number of Baseline Participants 4 3 11 12 3 3 43 44 123
Hide Baseline Analysis Population Description
Safety analysis set was defined as all participants who had received at least one dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 11 participants 12 participants 3 participants 3 participants 43 participants 44 participants 123 participants
<=18 years
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%
Between 18 and 65 years
1
  25.0%
1
  33.3%
7
  63.6%
4
  33.3%
3
 100.0%
0
   0.0%
12
  27.9%
13
  29.5%
41
  33.3%
>=65 years
3
  75.0%
2
  66.7%
4
  36.4%
8
  66.7%
0
   0.0%
3
 100.0%
31
  72.1%
31
  70.5%
82
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 11 participants 12 participants 3 participants 3 participants 43 participants 44 participants 123 participants
72.8  (6.5) 66.7  (9.07) 61.3  (11.14) 63.5  (11.41) 60.3  (0.58) 69  (3.61) 71.1  (10.18) 70.2  (8.61) 68.8  (9.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 11 participants 12 participants 3 participants 3 participants 43 participants 44 participants 123 participants
Female
0
   0.0%
1
  33.3%
2
  18.2%
5
  41.7%
0
   0.0%
1
  33.3%
10
  23.3%
11
  25.0%
30
  24.4%
Male
4
 100.0%
2
  66.7%
9
  81.8%
7
  58.3%
3
 100.0%
2
  66.7%
33
  76.7%
33
  75.0%
93
  75.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 11 participants 12 participants 3 participants 3 participants 43 participants 44 participants 123 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
1
   2.3%
2
   4.5%
5
   4.1%
Not Hispanic or Latino
4
 100.0%
0
   0.0%
9
  81.8%
10
  83.3%
3
 100.0%
3
 100.0%
39
  90.7%
37
  84.1%
105
  85.4%
Unknown or Not Reported
0
   0.0%
2
  66.7%
2
  18.2%
1
   8.3%
0
   0.0%
0
   0.0%
3
   7.0%
5
  11.4%
13
  10.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 11 participants 12 participants 3 participants 3 participants 43 participants 44 participants 123 participants
American Indian or Alaska Native
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%
Asian
0
   0.0%
0
   0.0%
2
  18.2%
0
   0.0%
1
  33.3%
1
  33.3%
3
   7.0%
2
   4.5%
9
   7.3%
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%
Black or African American
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%
White
4
 100.0%
1
  33.3%
6
  54.5%
11
  91.7%
2
  66.7%
2
  66.7%
36
  83.7%
36
  81.8%
98
  79.7%
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%
Unknown or Not Reported
0
   0.0%
2
  66.7%
3
  27.3%
1
   8.3%
0
   0.0%
0
   0.0%
4
   9.3%
6
  13.6%
16
  13.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 4 participants 3 participants 11 participants 12 participants 3 participants 3 participants 43 participants 44 participants 123 participants
BELARUS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   9.3%
6
  13.6%
10
   8.1%
BELGIUM
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
1
  33.3%
2
   4.7%
1
   2.3%
5
   4.1%
BRAZIL
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.7%
1
   2.3%
3
   2.4%
FRANCE
0
   0.0%
2
  66.7%
2
  18.2%
1
   8.3%
0
   0.0%
0
   0.0%
3
   7.0%
4
   9.1%
12
   9.8%
ITALY
0
   0.0%
0
   0.0%
1
   9.1%
2
  16.7%
0
   0.0%
0
   0.0%
3
   7.0%
2
   4.5%
8
   6.5%
POLAND
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
1
   0.8%
RUSSIAN FEDERATION
0
   0.0%
0
   0.0%
1
   9.1%
1
   8.3%
2
  66.7%
1
  33.3%
8
  18.6%
8
  18.2%
21
  17.1%
SOUTH KOREA
0
   0.0%
0
   0.0%
2
  18.2%
0
   0.0%
1
  33.3%
1
  33.3%
2
   4.7%
2
   4.5%
8
   6.5%
SPAIN
2
  50.0%
1
  33.3%
4
  36.4%
6
  50.0%
0
   0.0%
0
   0.0%
4
   9.3%
8
  18.2%
25
  20.3%
TAIWAN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
1
   0.8%
TURKEY
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9
  20.9%
8
  18.2%
17
  13.8%
UNITED KINGDOM
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   7.0%
0
   0.0%
3
   2.4%
UNITED STATES
2
  50.0%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
0
   0.0%
2
   4.7%
3
   6.8%
9
   7.3%
1.Primary Outcome
Title Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Hide Description Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated analysis set included all participants who had received at least one dose of study drug.
Arm/Group Title Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
Hide Arm/Group Description:
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Overall Number of Participants Analyzed 4 3 11 12 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
Hide Description ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
Time Frame From Day 1 up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treated analysis set included all participants who had received at least one dose of study drug.
Arm/Group Title Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Hide Arm/Group Description:
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Overall Number of Participants Analyzed 43 44
Measure Type: Number
Unit of Measure: Percentage of Participants
44.2 54.5
3.Primary Outcome
Title Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Hide Description Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
Time Frame From Day 1 up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treated analysis set included all participants who had received at least one dose of study drug.
Arm/Group Title Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Hide Arm/Group Description:
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
Overall Number of Participants Analyzed 43 44
Measure Type: Count of Participants
Unit of Measure: Participants
43
 100.0%
44
 100.0%
4.Secondary Outcome
Title Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Phase 1b and Phase 2: Serum Concentration of Cetrelimab
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Phase 2: Number of Participants With Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Phase 2: Number of Participants With Abnormal Laboratory Values
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Phase 2: Duration of Response (DoR)
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Phase 2: Time to Response (TTR)
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Phase 2: Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Phase 2: Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Up to 6 years 1 month
Outcome Measure Data Not Reported
Time Frame Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Adverse Event Reporting Description Treated analysis set included all participants who had received at least one dose of study drug.
 
Arm/Group Title Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Hide Arm/Group Description Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met. Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
All-Cause Mortality
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
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   4/4 (100.00%)   3/3 (100.00%)   5/11 (45.45%)   3/12 (25.00%)   2/3 (66.67%)   2/3 (66.67%)   21/43 (48.84%)   17/44 (38.64%) 
Hide Serious Adverse Events
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
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   3/4 (75.00%)   1/3 (33.33%)   4/11 (36.36%)   6/12 (50.00%)   3/3 (100.00%)   1/3 (33.33%)   22/43 (51.16%)   19/44 (43.18%) 
Blood and lymphatic system disorders                 
Anaemia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Disseminated Intravascular Coagulation * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Thrombocytopenia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Cardiac disorders                 
Atrial Flutter * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Endocrine disorders                 
Hyperthyroidism * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Eye disorders                 
Maculopathy * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Punctate Keratitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Serous Retinal Detachment * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Ulcerative Keratitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Gastrointestinal disorders                 
Constipation * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Diarrhoea * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Gastric Ulcer * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Inguinal Hernia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Intestinal Mass * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Intestinal Obstruction * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Large Intestinal Obstruction * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Large Intestine Perforation * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Small Intestinal Obstruction * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Stomatitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Vomiting * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
General disorders                 
Asthenia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Fatigue * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
General Physical Health Deterioration * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  3/43 (6.98%)  1/44 (2.27%) 
Pain * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Pyrexia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  0/44 (0.00%) 
Hepatobiliary disorders                 
Cholecystitis Acute * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Infections and infestations                 
Abdominal Infection * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Cellulitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Cholecystitis Infective * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Covid-19 * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Covid-19 Pneumonia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Epididymitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Febrile Infection * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Herpes Ophthalmic * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Infection * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Peritonitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pneumonia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  1/44 (2.27%) 
Pyelonephritis * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pyelonephritis Acute * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  0/44 (0.00%) 
Pyelonephritis Chronic * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Respiratory Tract Infection * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Sepsis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Urinary Tract Infection * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Urosepsis * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Injury, poisoning and procedural complications                 
Hip Fracture * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Investigations                 
Blood Creatinine Increased * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Metabolism and nutrition disorders                 
Decreased Appetite * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Hyponatraemia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  3/44 (6.82%) 
Hypophagia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Type 1 Diabetes Mellitus * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Musculoskeletal and connective tissue disorders                 
Mobility Decreased * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Osteoarthritis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Cancer Pain * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Colorectal Cancer * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Infected Neoplasm * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Tumour Pain * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Tumour Perforation * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Nervous system disorders                 
Cerebrovascular Accident * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Syncope * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Renal and urinary disorders                 
Acute Kidney Injury * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Chronic Kidney Disease * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Haematuria * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Renal Failure * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Urinary Retention * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Urinary Tract Obstruction * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders                 
Aspiration * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pneumonitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Respiratory Distress * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Respiratory Failure * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Skin and subcutaneous tissue disorders                 
Erythema Nodosum * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Rash Maculo-Papular * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Vascular disorders                 
Hypovolaemic Shock * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
1
Term from vocabulary, MedDRA Version 24.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
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   4/4 (100.00%)   3/3 (100.00%)   11/11 (100.00%)   12/12 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   43/43 (100.00%)   43/44 (97.73%) 
Blood and lymphatic system disorders                 
Anaemia * 1  1/4 (25.00%)  1/3 (33.33%)  2/11 (18.18%)  3/12 (25.00%)  3/3 (100.00%)  2/3 (66.67%)  16/43 (37.21%)  17/44 (38.64%) 
Iron Deficiency Anaemia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Lymphopenia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  2/44 (4.55%) 
Thrombocytopenia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Cardiac disorders                 
Angina Pectoris * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Cardiac Failure * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Sinus Bradycardia * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Sinus Tachycardia * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Tachycardia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Ear and labyrinth disorders                 
Hypoacusis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Tinnitus * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/43 (2.33%)  0/44 (0.00%) 
Endocrine disorders                 
Hyperparathyroidism * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Hyperthyroidism * 1  1/4 (25.00%)  0/3 (0.00%)  2/11 (18.18%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Hypothyroidism * 1  1/4 (25.00%)  1/3 (33.33%)  2/11 (18.18%)  3/12 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  3/44 (6.82%) 
Eye disorders                 
Cataract * 1  0/4 (0.00%)  1/3 (33.33%)  2/11 (18.18%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  3/44 (6.82%) 
Chorioretinopathy * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  1/3 (33.33%)  1/43 (2.33%)  2/44 (4.55%) 
Conjunctival Hyperaemia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Detachment of Macular Retinal Pigment Epithelium * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Detachment of Retinal Pigment Epithelium * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Dry Eye * 1  1/4 (25.00%)  0/3 (0.00%)  1/11 (9.09%)  2/12 (16.67%)  1/3 (33.33%)  1/3 (33.33%)  2/43 (4.65%)  6/44 (13.64%) 
Eye Discharge * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Eye Pain * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Eye Pruritus * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Eyelid Oedema * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Keratitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  5/43 (11.63%)  5/44 (11.36%) 
Lacrimal Disorder * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Lacrimation Increased * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  2/44 (4.55%) 
Macular Detachment * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Photophobia * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Posterior Capsule Opacification * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Retinal Detachment * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Serous Retinal Detachment * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  2/44 (4.55%) 
Trichiasis * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Ulcerative Keratitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Uveitis * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Vision Blurred * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  1/12 (8.33%)  1/3 (33.33%)  0/3 (0.00%)  5/43 (11.63%)  4/44 (9.09%) 
Visual Acuity Reduced * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  2/44 (4.55%) 
Visual Impairment * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  4/44 (9.09%) 
Vitreous Floaters * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Xerophthalmia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  2/44 (4.55%) 
Gastrointestinal disorders                 
Abdominal Pain * 1  0/4 (0.00%)  0/3 (0.00%)  4/11 (36.36%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  1/44 (2.27%) 
Abdominal Pain Upper * 1  0/4 (0.00%)  1/3 (33.33%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  2/44 (4.55%) 
Anal Fissure * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Anal Fistula * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Anal Inflammation * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Anal Ulcer * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Aphthous Ulcer * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Colitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Constipation * 1  0/4 (0.00%)  2/3 (66.67%)  5/11 (45.45%)  4/12 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  14/43 (32.56%)  7/44 (15.91%) 
Dental Caries * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Diarrhoea * 1  1/4 (25.00%)  1/3 (33.33%)  9/11 (81.82%)  10/12 (83.33%)  1/3 (33.33%)  0/3 (0.00%)  21/43 (48.84%)  20/44 (45.45%) 
Dry Mouth * 1  2/4 (50.00%)  2/3 (66.67%)  6/11 (54.55%)  7/12 (58.33%)  1/3 (33.33%)  2/3 (66.67%)  16/43 (37.21%)  26/44 (59.09%) 
Gastrointestinal Pain * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  0/44 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  0/44 (0.00%) 
Gingival Disorder * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Haematemesis * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Haemorrhoids * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Mallory-Weiss Syndrome * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Nausea * 1  1/4 (25.00%)  0/3 (0.00%)  4/11 (36.36%)  3/12 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  9/43 (20.93%)  4/44 (9.09%) 
Odynophagia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Proctitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Rectal Haemorrhage * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Stomatitis * 1  3/4 (75.00%)  3/3 (100.00%)  3/11 (27.27%)  9/12 (75.00%)  1/3 (33.33%)  2/3 (66.67%)  31/43 (72.09%)  26/44 (59.09%) 
Toothache * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Vomiting * 1  1/4 (25.00%)  1/3 (33.33%)  2/11 (18.18%)  2/12 (16.67%)  0/3 (0.00%)  2/3 (66.67%)  4/43 (9.30%)  3/44 (6.82%) 
General disorders                 
Asthenia * 1  0/4 (0.00%)  1/3 (33.33%)  4/11 (36.36%)  7/12 (58.33%)  1/3 (33.33%)  0/3 (0.00%)  5/43 (11.63%)  10/44 (22.73%) 
Chills * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Face Oedema * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Fatigue * 1  2/4 (50.00%)  0/3 (0.00%)  2/11 (18.18%)  1/12 (8.33%)  0/3 (0.00%)  1/3 (33.33%)  10/43 (23.26%)  11/44 (25.00%) 
General Physical Health Deterioration * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Localised Oedema * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Malaise * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Non-Cardiac Chest Pain * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Oedema Peripheral * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  2/44 (4.55%) 
Pain * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pyrexia * 1  2/4 (50.00%)  0/3 (0.00%)  2/11 (18.18%)  4/12 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  4/43 (9.30%)  4/44 (9.09%) 
Xerosis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hepatobiliary disorders                 
Autoimmune Hepatitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Gallbladder Polyp * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hepatobiliary Disease * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hyperbilirubinaemia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  4/43 (9.30%)  2/44 (4.55%) 
Immune system disorders                 
Drug Hypersensitivity * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Infections and infestations                 
Cellulitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Conjunctivitis * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  4/12 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  3/44 (6.82%) 
Covid-19 * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  5/43 (11.63%)  6/44 (13.64%) 
Dermatophytosis * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Fungal Skin Infection * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Furuncle * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Genital Herpes * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Herpes Virus Infection * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Klebsiella Bacteraemia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Laryngitis * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Lip Infection * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Nail Infection * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/43 (2.33%)  1/44 (2.27%) 
Nasopharyngitis * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Onychomycosis * 1  0/4 (0.00%)  1/3 (33.33%)  1/11 (9.09%)  3/12 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Oral Candidiasis * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Oral Herpes * 1  1/4 (25.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Otitis Externa * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Paronychia * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  10/43 (23.26%)  4/44 (9.09%) 
Perirectal Abscess * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pneumonia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Pyelonephritis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  1/44 (2.27%) 
Rash Pustular * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Respiratory Tract Infection * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Sinusitis * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Skin Bacterial Infection * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Skin Candida * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Strongyloidiasis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Subcutaneous Abscess * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Upper Respiratory Tract Infection * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Urinary Tract Infection * 1  2/4 (50.00%)  0/3 (0.00%)  2/11 (18.18%)  4/12 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  4/43 (9.30%)  6/44 (13.64%) 
Vaginal Infection * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Injury, poisoning and procedural complications                 
Corneal Abrasion * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Foot Fracture * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Overdose * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Persistent Corneal Epithelial Defect * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Skin Laceration * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Investigations                 
Alanine Aminotransferase Increased * 1  0/4 (0.00%)  0/3 (0.00%)  4/11 (36.36%)  1/12 (8.33%)  1/3 (33.33%)  1/3 (33.33%)  14/43 (32.56%)  11/44 (25.00%) 
Aspartate Aminotransferase Increased * 1  0/4 (0.00%)  0/3 (0.00%)  3/11 (27.27%)  2/12 (16.67%)  2/3 (66.67%)  1/3 (33.33%)  10/43 (23.26%)  8/44 (18.18%) 
Blood Alkaline Phosphatase Increased * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  1/3 (33.33%)  0/3 (0.00%)  3/43 (6.98%)  5/44 (11.36%) 
Blood Calcium Increased * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Blood Creatinine Increased * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  3/12 (25.00%)  1/3 (33.33%)  0/3 (0.00%)  7/43 (16.28%)  10/44 (22.73%) 
Blood Parathyroid Hormone Increased * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Blood Thyroid Stimulating Hormone Increased * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Blood Urea Increased * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Gamma-Glutamyltransferase Increased * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  2/44 (4.55%) 
International Normalised Ratio Increased * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Lipase Increased * 1  0/4 (0.00%)  0/3 (0.00%)  4/11 (36.36%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  6/43 (13.95%)  8/44 (18.18%) 
Weight Decreased * 1  0/4 (0.00%)  2/3 (66.67%)  2/11 (18.18%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  7/43 (16.28%)  8/44 (18.18%) 
Metabolism and nutrition disorders                 
Decreased Appetite * 1  2/4 (50.00%)  0/3 (0.00%)  3/11 (27.27%)  5/12 (41.67%)  1/3 (33.33%)  0/3 (0.00%)  8/43 (18.60%)  9/44 (20.45%) 
Dehydration * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Diabetes Mellitus * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  2/44 (4.55%) 
Hyperamylasaemia * 1  0/4 (0.00%)  0/3 (0.00%)  3/11 (27.27%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  4/43 (9.30%)  6/44 (13.64%) 
Hypercalcaemia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  4/43 (9.30%)  1/44 (2.27%) 
Hypercholesterolaemia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hyperglycaemia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  3/44 (6.82%) 
Hyperkalaemia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  5/43 (11.63%)  2/44 (4.55%) 
Hyperphosphataemia * 1  1/4 (25.00%)  2/3 (66.67%)  8/11 (72.73%)  10/12 (83.33%)  3/3 (100.00%)  3/3 (100.00%)  36/43 (83.72%)  30/44 (68.18%) 
Hypoalbuminaemia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  4/44 (9.09%) 
Hypocalcaemia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  5/44 (11.36%) 
Hypochloraemia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hypokalaemia * 1  1/4 (25.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  3/44 (6.82%) 
Hypomagnesaemia * 1  1/4 (25.00%)  0/3 (0.00%)  1/11 (9.09%)  3/12 (25.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  2/44 (4.55%) 
Hyponatraemia * 1  1/4 (25.00%)  1/3 (33.33%)  2/11 (18.18%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  9/43 (20.93%)  7/44 (15.91%) 
Hypophagia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hypophosphataemia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  3/44 (6.82%) 
Iron Deficiency * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  3/12 (25.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  2/44 (4.55%) 
Back Pain * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  3/12 (25.00%)  0/3 (0.00%)  1/3 (33.33%)  2/43 (4.65%)  4/44 (9.09%) 
Bone Pain * 1  0/4 (0.00%)  2/3 (66.67%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Flank Pain * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  0/44 (0.00%) 
Groin Pain * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  0/44 (0.00%) 
Muscle Spasms * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Myalgia * 1  1/4 (25.00%)  0/3 (0.00%)  2/11 (18.18%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Myopathy * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pain in Extremity * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  3/43 (6.98%)  1/44 (2.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Cardiac Myxoma * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Skin Papilloma * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Tumour Pain * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  1/44 (2.27%) 
Nervous system disorders                 
Ageusia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  3/43 (6.98%)  1/44 (2.27%) 
Disturbance in Attention * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  0/44 (0.00%) 
Dizziness * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  3/44 (6.82%) 
Dysgeusia * 1  2/4 (50.00%)  2/3 (66.67%)  2/11 (18.18%)  4/12 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  7/43 (16.28%)  9/44 (20.45%) 
Encephalopathy * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Headache * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  1/3 (33.33%)  1/3 (33.33%)  5/43 (11.63%)  1/44 (2.27%) 
Lethargy * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Mental Impairment * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Paraesthesia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Peripheral Sensorimotor Neuropathy * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Peripheral Sensory Neuropathy * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  0/44 (0.00%) 
Sciatica * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Syncope * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  3/44 (6.82%) 
Tremor * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  0/44 (0.00%) 
Psychiatric disorders                 
Adjustment Disorder * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Depression * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Insomnia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  1/3 (33.33%)  0/3 (0.00%)  2/43 (4.65%)  2/44 (4.55%) 
Mixed Anxiety and Depressive Disorder * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Nervousness * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Renal and urinary disorders                 
Acute Kidney Injury * 1  2/4 (50.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Dysuria * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  2/44 (4.55%) 
Haematuria * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  1/12 (8.33%)  0/3 (0.00%)  1/3 (33.33%)  6/43 (13.95%)  3/44 (6.82%) 
Hydronephrosis * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Nephropathy Toxic * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pollakiuria * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  0/44 (0.00%) 
Proteinuria * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Renal Failure * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  0/44 (0.00%) 
Renal Impairment * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  2/12 (16.67%)  1/3 (33.33%)  0/3 (0.00%)  3/43 (6.98%)  2/44 (4.55%) 
Renal Pain * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/43 (0.00%)  0/44 (0.00%) 
Urinary Tract Pain * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Reproductive system and breast disorders                 
Benign Prostatic Hyperplasia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Gynaecomastia * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Scrotal Dermatitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Scrotal Oedema * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Testicular Cyst * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Vulvovaginal Pruritus * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough * 1  2/4 (50.00%)  0/3 (0.00%)  1/11 (9.09%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  4/43 (9.30%)  1/44 (2.27%) 
Dysphonia * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  3/44 (6.82%) 
Dyspnoea * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  1/3 (33.33%)  2/43 (4.65%)  3/44 (6.82%) 
Dyspnoea Exertional * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Epistaxis * 1  1/4 (25.00%)  1/3 (33.33%)  4/11 (36.36%)  2/12 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  3/43 (6.98%)  3/44 (6.82%) 
Haemoptysis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hiccups * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Hypoxia * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Lung Infiltration * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Nasal Congestion * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/43 (2.33%)  1/44 (2.27%) 
Nasal Dryness * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  1/43 (2.33%)  3/44 (6.82%) 
Oropharyngeal Pain * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  2/44 (4.55%) 
Pneumonitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Pulmonary Embolism * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Rhinorrhoea * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Skin and subcutaneous tissue disorders                 
Alopecia * 1  0/4 (0.00%)  2/3 (66.67%)  4/11 (36.36%)  4/12 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  6/43 (13.95%)  5/44 (11.36%) 
Dermal Cyst * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Dermatitis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Dermatitis Acneiform * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Dry Skin * 1  1/4 (25.00%)  2/3 (66.67%)  2/11 (18.18%)  4/12 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  15/43 (34.88%)  17/44 (38.64%) 
Erythema * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Hand Dermatitis * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hyperkeratosis * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Lichen Planus * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Lichen Sclerosus * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Nail Discolouration * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  7/43 (16.28%)  3/44 (6.82%) 
Nail Disorder * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  3/12 (25.00%)  1/3 (33.33%)  0/3 (0.00%)  4/43 (9.30%)  6/44 (13.64%) 
Nail Dystrophy * 1  0/4 (0.00%)  1/3 (33.33%)  4/11 (36.36%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  5/43 (11.63%)  8/44 (18.18%) 
Nail Ridging * 1  1/4 (25.00%)  0/3 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  2/44 (4.55%) 
Nail Toxicity * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  1/43 (2.33%)  0/44 (0.00%) 
Onychalgia * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  2/44 (4.55%) 
Onycholysis * 1  0/4 (0.00%)  1/3 (33.33%)  4/11 (36.36%)  4/12 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  6/43 (13.95%)  8/44 (18.18%) 
Onychomadesis * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  5/43 (11.63%)  4/44 (9.09%) 
Palmar-Plantar Erythrodysaesthesia Syndrome * 1  0/4 (0.00%)  2/3 (66.67%)  3/11 (27.27%)  4/12 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  11/43 (25.58%)  10/44 (22.73%) 
Pruritus * 1  1/4 (25.00%)  1/3 (33.33%)  2/11 (18.18%)  5/12 (41.67%)  0/3 (0.00%)  0/3 (0.00%)  3/43 (6.98%)  5/44 (11.36%) 
Psoriasis * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Rash * 1  0/4 (0.00%)  0/3 (0.00%)  2/11 (18.18%)  2/12 (16.67%)  0/3 (0.00%)  1/3 (33.33%)  1/43 (2.33%)  1/44 (2.27%) 
Rash Maculo-Papular * 1  1/4 (25.00%)  0/3 (0.00%)  2/11 (18.18%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  1/44 (2.27%) 
Rash Papular * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Skin Fissures * 1  0/4 (0.00%)  1/3 (33.33%)  1/11 (9.09%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  2/43 (4.65%)  1/44 (2.27%) 
Skin Hyperpigmentation * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Skin Lesion * 1  0/4 (0.00%)  1/3 (33.33%)  0/11 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Vascular disorders                 
Embolism * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
Hypertension * 1  0/4 (0.00%)  0/3 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  3/44 (6.82%) 
Hypotension * 1  1/4 (25.00%)  1/3 (33.33%)  0/11 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  1/43 (2.33%)  3/44 (6.82%) 
Peripheral Venous Disease * 1  0/4 (0.00%)  0/3 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/43 (0.00%)  0/44 (0.00%) 
1
Term from vocabulary, MedDRA Version 24.1
*
Indicates events were collected by non-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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Medical Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03473743    
Other Study ID Numbers: CR108445
2017-001980-19 ( EudraCT Number )
42756493BLC2002 ( Other Identifier: Janssen Research & Development, LLC )
2023-510295-31-00 ( Registry Identifier: EUCT number )
First Submitted: March 14, 2018
First Posted: March 22, 2018
Results First Submitted: September 29, 2023
Results First Posted: October 25, 2023
Last Update Posted: April 25, 2024