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Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (PLATforM)

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: NCT03484923
Recruitment Status : Completed
First Posted : April 2, 2018
Results First Posted : January 18, 2024
Last Update Posted : January 18, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: PDR001
Drug: LAG525
Drug: INC280
Drug: ACZ885
Drug: LEE011
Enrollment 196
Recruitment Details None of the arms were opened in the extension part.
Pre-assignment Details The screening period began once written informed consent was provided and ended after 28 days (or after 35 days for subjects screened for Arm 1A) or when subject was randomized/enrolled, whichever came first. 1 participant randomized to Arm 3 discontinued before study treatment due to an AE.
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Period Title: Overall Study
Started 45 43 43 44 21
Treated 45 43 42 44 21
Completed 0 0 0 0 0
Not Completed 45 43 43 44 21
Reason Not Completed
Adverse Event             3             3             5             11             1
Death             2             2             3             0             1
Physician Decision             6             7             6             3             2
Progressive disease             33             28             26             30             16
Subject Decision             1             3             3             0             1
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section) Total
Hide Arm/Group Description Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 45 43 43 44 21 196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 43 participants 43 participants 44 participants 21 participants 196 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  64.4%
29
  67.4%
28
  65.1%
28
  63.6%
8
  38.1%
122
  62.2%
>=65 years
16
  35.6%
14
  32.6%
15
  34.9%
16
  36.4%
13
  61.9%
74
  37.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 43 participants 43 participants 44 participants 21 participants 196 participants
Female
17
  37.8%
21
  48.8%
15
  34.9%
14
  31.8%
9
  42.9%
76
  38.8%
Male
28
  62.2%
22
  51.2%
28
  65.1%
30
  68.2%
12
  57.1%
120
  61.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 43 participants 43 participants 44 participants 21 participants 196 participants
American Indian or Alaska Native
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%
1
   2.3%
0
   0.0%
1
   4.8%
2
   1.0%
Native Hawaiian or Other Pacific Islander
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%
White
45
 100.0%
42
  97.7%
38
  88.4%
42
  95.5%
20
  95.2%
187
  95.4%
More than one race
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
   2.3%
4
   9.3%
2
   4.5%
0
   0.0%
7
   3.6%
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description

ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI).

CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time Frame Up to 49 months (randomized section) and 18 months (non-randomized section)
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: All participants to whom study treatment was assigned by randomization.

Non-randomized section: All participants who received at least one dose of study treatment
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 45 43 43 44 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
8.9
(2.5 to 21.2)
4.7
(0.6 to 15.8)
4.7
(0.6 to 15.8)
6.8
(1.4 to 18.7)
14.3
(3.0 to 36.3)
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description

DOR defined as the time from date of first documented CR or PR to date of first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. Subjects continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment.

CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time Frame From first documented response to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized part) and 18 months (non-randomized part)
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: All participants to whom study treatment was assigned by randomization for whom best overall response was complete response or partial response.

Non-randomized section: All participants who received at least one dose of study treatment for whom best overall response was complete response or partial response
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 4 2 2 3 3
Median (Full Range)
Unit of Measure: Days
476
(169 to 1373)
941.5
(504 to 1379)
617.5
(113 to 1122)
217
(169 to 281)
281
(169 to 449)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from date of randomization (or date of first dose of study treatment in non-randomized part) to date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method, and the medians and 95% confidence intervals of the medians were presented.
Time Frame From randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section)
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: All participants to whom study treatment was assigned by randomization.

Non-randomized section: All participants who received at least one dose of study treatment
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 45 43 43 44 21
Median (95% Confidence Interval)
Unit of Measure: Months
8.8
(6.3 to 21.4)
12.1
(6.6 to 18.5)
8.7
(5.7 to 17.9)
10.1
(7.4 to 15.6)
14.0 [1] 
(8.4 to NA)
[1]
NA: Not estimable due to the insufficient number of participants with events
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time between the date of randomization (or date of first dose of study treatment in non-randomized section) to the date of event defined as the first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. If a subject had not had an event before leaving study or initiation of subsequent anticancer therapy, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using the Kaplan-Meier method, medians and 95% confidence interval of the medians were presented.
Time Frame From randomization (or start of treatment for non-randomized section) to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized section) and 18 months (non-randomized section)
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: All participants to whom study treatment was assigned by randomization.

Non-randomized section: All participants who received at least one dose of study treatment
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 45 43 43 44 21
Median (95% Confidence Interval)
Unit of Measure: Months
2.7
(1.7 to 2.8)
2.7
(2.4 to 2.8)
2.7
(2.6 to 2.8)
2.8
(2.7 to 4.4)
2.8
(2.7 to 4.6)
5.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description

DCR was defined as the percentage of participants with best overall response of CR, PR or stable disease (SD) (as per local review by RECIST v1.1 and assessed by CT/MRI).

CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Time Frame Up to 49 months (randomized section) and 18 months (non-randomized section)
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: All participants to whom study treatment was assigned by randomization.

Non-randomized section: All participants who received at least one dose of study treatment
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 45 43 43 44 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
15.6
(6.5 to 29.5)
16.3
(6.8 to 30.7)
18.6
(8.4 to 33.4)
31.8
(18.6 to 47.6)
33.3
(14.6 to 57.0)
6.Secondary Outcome
Title Percentage of Participants With PDR001 Anti-drug Antibodies (ADA) Positive Result at Baseline
Hide Description Percentage of participants who had a PDR001 ADA positive result at baseline.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: Participants to whom study treatment was assigned by randomization with a determinant baseline immunogenicity sample for PDR001.

Non-randomized section: Participants who received at least one dose of treatment with a determinant baseline immunogenicity sample for PDR001.
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 43 38 40 41 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.3%
0
   0.0%
1
   2.5%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Percentage of Participants With LAG525 Anti-drug Antibodies (ADA) Positive Result at Baseline
Hide Description Percentage of participants who had a LAG525 ADA positive result at baseline. Only applicable for participants enrolled in Arm 1 and Arm 1A.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: Participants randomized to Arm 1 with a determinant baseline immunogenicity sample for LAG525.

Non-randomized section: Participants who received at least one dose of treatment with a determinant baseline immunogenicity sample for LAG525.
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 43 20
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.0%
0
   0.0%
8.Secondary Outcome
Title Percentage of Participants With ACZ885 Anti-drug Antibodies (ADA) Positive Result at Baseline
Hide Description Percentage of participants who had an ACZ885 ADA positive result at baseline. Only applicable for subjects enrolled in Arm 3.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to Arm 3 with a determinant baseline immunogenicity sample for ACZ885.
Arm/Group Title Arm 3: ACZ885 + PDR001 (Randomized Section)
Hide Arm/Group Description:
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
9.Secondary Outcome
Title Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for PDR001
Hide Description Percentage of participants who tested positive for treatment-induced ADA for PDR001 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for PDR001 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment).
Time Frame Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT), EOT, and 30 and 150 days post-EOT (assessed up to 49 months randomized section and 24 months non-randomized section). Cycle= 28 days
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: Participants to whom study treatment was assigned by randomization with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.

Non-randomized section: Participants who received at least one dose of study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 40 34 38 39 19
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.5%
5
  14.7%
3
   7.9%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for LAG525
Hide Description Percentage of participants who tested positive for treatment-induced ADA for LAG525 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for LAG525 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 1 and Arm 1A.
Time Frame Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 49 months in the randomized section and 18 months in the non-randomized section). Cycle= 28 days
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized section: Participants randomized to Arm 1 with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.

Non-randomized section: Participants who received at least one dose of study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 40 19
Measure Type: Count of Participants
Unit of Measure: Participants
7
  17.5%
2
  10.5%
11.Secondary Outcome
Title Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for ACZ885
Hide Description Percentage of participants who tested positive for treatment-induced ADA for ACZ885 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for ACZ885 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 3.
Time Frame Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 40 months). Cycle= 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to Arm 3 with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.
Arm/Group Title Arm 3: ACZ885 + PDR001 (Randomized Section)
Hide Arm/Group Description:
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.6%
12.Secondary Outcome
Title Percentage of Participants With a Favorable Biomarker Profile (pFBP)
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Biomarker parameters included: 1) number of tumor infiltrating T cells (TIL), 2) activation level of TIL, and 3) changes in immune response gene expression signatures. For the number of TILs, an increase in tumoral CD8+ cell numbers compared to baseline was considered favorable. The activation level of TIL was assessed by the percentage of tumoral CD8+ cells expressing GzmB (a marker for cytotoxic activity) or Ki67 (a marker for cell proliferation), where an increase in either GZMB+/CD8+ or KI67+/CD8+ post-baseline was considered favorable. Changes in immune response gene expression signatures were evaluated by the levels in T-cell inflamed signature (TIS), where an increase from baseline was considered favorable.

To be categorized as having a pFBP, a subject must meet the favorable criteria for at least two of the three biomarker parameters. The percentage of participants with pFBP was assessed.
Time Frame Baseline and after 3-4 weeks of treatment
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Participants who received at least one dose of treatment with an evaluable baseline tumor biopsy sample and at least one evaluable post-baseline tumor biopsy sample with evaluable results for the three biomarker parameters.
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
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Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 22 21 31 6 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
13.6
(2.9 to 34.9)
4.8
(0.1 to 23.8)
6.5
(0.8 to 21.4)
16.7
(0.4 to 64.1)
13.Post-Hoc Outcome
Title All Collected Deaths
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Pre-treatment: deaths collected from day of patient's informed consent to the day before the first administration of study treatment.

On-treatment: deaths collected from start of treatment to 30 days after last dose of study treatment.

Extended safety follow-up: deaths collected from 31 days after last dose of study treatment up to 150 days after last dose of PDR001 (if this timepoint was later than 30 days after last dose of study treatment) Post-treatment survival follow-up: deaths collected from day 151 post-last dose of PDR001 or 31 days after last dose of study treatment (whichever occurred last) up to end of study.
Time Frame Pre-treatment: up to 28/35 days (randomized/non-randomized). On-treatment: up to 49/19 months (randomized/non-randomized). Extended safety FU and Post-treatment survival FU: up to 49/24 months (randomized/non-randomized).
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Randomized section: All participants to whom study treatment was assigned by randomization.

Non-randomized section: All participants who received at least one dose of study treatment
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Section) Arm 2: INC280+PDR001 (Randomized Section) Arm 3: ACZ885 + PDR001 (Randomized Section) Arm 4: LEE011 + PDR001 (Randomized Section) Arm 1A: LAG525 + PDR001 (Non-randomized Section)
Hide Arm/Group Description:
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Number of Participants Analyzed 45 43 43 44 21
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-treatment deaths Number Analyzed 45 participants 43 participants 43 participants 44 participants 21 participants
0 0 0 0 0
On-treatment deaths Number Analyzed 45 participants 43 participants 42 participants 44 participants 21 participants
5 3 3 3 1
Extended safety follow-up deaths Number Analyzed 45 participants 43 participants 42 participants 44 participants 21 participants
14 11 15 11 4
Post-treatment survival follow-up deaths Number Analyzed 26 participants 29 participants 24 participants 30 participants 14 participants
18 19 15 19 7
All deaths Number Analyzed 45 participants 43 participants 43 participants 44 participants 21 participants
37 33 33 33 12
Time Frame On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Adverse Event Reporting Description Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
 
Arm/Group Title Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
Hide Arm/Group Description AEs collected during on-treatment period (up to 30 days post-treatment) AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 [if >30 days post-treatment]) Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period AEs collected during on-treatment period (up to 30 days post-treatment) AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 [if >30 days post-treatment]) Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period AEs collected during on-treatment period (up to 30 days post-treatment) AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 [if >30 days post-treatment]) Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period AEs collected during on-treatment period (up to 30 days post-treatment) AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 [if >30 days post-treatment]) Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period AEs collected during on-treatment period (up to 30 days post-treatment) AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 [if >30 days post-treatment]) Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
All-Cause Mortality
Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/45 (11.11%)   14/45 (31.11%)   18/26 (69.23%)   3/43 (6.98%)   11/43 (25.58%)   19/29 (65.52%)   3/42 (7.14%)   15/42 (35.71%)   15/24 (62.50%)   3/44 (6.82%)   11/44 (25.00%)   19/30 (63.33%)   1/21 (4.76%)   4/21 (19.05%)   7/14 (50.00%) 
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Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/45 (46.67%)   5/45 (11.11%)   0/0   21/43 (48.84%)   0/43 (0.00%)   0/0   12/42 (28.57%)   4/42 (9.52%)   0/0   22/44 (50.00%)   8/44 (18.18%)   0/0   7/21 (33.33%)   2/21 (9.52%)   0/0 
Blood and lymphatic system disorders                               
Anaemia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Febrile neutropenia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Cardiac disorders                               
Acute myocardial infarction † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Atrial fibrillation † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Myocarditis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Endocrine disorders                               
Adrenal haematoma † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hypercalcaemia of malignancy † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  1/21 (4.76%)  /0 
Gastrointestinal disorders                               
Abdominal pain † 1  0/45 (0.00%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Autoimmune colitis † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Diarrhoea † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  1/42 (2.38%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Dysphagia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Gastritis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Gastrointestinal haemorrhage † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Gastrooesophageal reflux disease † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Immune-mediated enterocolitis † 1  0/45 (0.00%)  1/45 (2.22%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Intestinal obstruction † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Intussusception † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Lower gastrointestinal haemorrhage † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Nausea † 1  2/45 (4.44%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Small intestinal obstruction † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Subileus † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Vomiting † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  1/42 (2.38%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
General disorders                               
Asthenia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Chest pain † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Fatigue † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
General physical health deterioration † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  1/42 (2.38%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Heteroplasia † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Multiple organ dysfunction syndrome † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Oedema peripheral † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pain † 1  0/45 (0.00%)  1/45 (2.22%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pyrexia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  2/44 (4.55%)  2/44 (4.55%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hepatobiliary disorders                               
Cholangitis † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Drug-induced liver injury † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hepatic cytolysis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hepatitis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hepatitis acute † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hypertransaminasaemia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Immune-mediated hepatitis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Immune system disorders                               
Cytokine release syndrome † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Drug hypersensitivity † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Infections and infestations                               
Cellulitis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Erysipelas † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Infection † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pneumonia † 1  0/45 (0.00%)  2/45 (4.44%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pneumonia bacterial † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Respiratory tract infection † 1  0/45 (0.00%)  1/45 (2.22%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Sepsis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Skin infection † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Suspected COVID-19 † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Injury, poisoning and procedural complications                               
Femur fracture † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Humerus fracture † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Ocular procedural complication † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Investigations                               
Blood lactic acid increased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
General physical condition abnormal † 1  2/45 (4.44%)  1/45 (2.22%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  1/42 (2.38%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Haemoglobin decreased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Liver function test abnormal † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Liver function test increased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Metabolism and nutrition disorders                               
Cachexia † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Decreased appetite † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Dehydration † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Diabetes mellitus † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hypoalbuminaemia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hypokalaemia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hyponatraemia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  1/21 (4.76%)  /0 
Musculoskeletal and connective tissue disorders                               
Arthralgia † 1  1/45 (2.22%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Back pain † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Myositis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pain in extremity † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  2/44 (4.55%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pathological fracture † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Rhabdomyolysis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                               
Acute myeloid leukaemia † 1  0/45 (0.00%)  1/45 (2.22%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Basal cell carcinoma † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Breast neoplasm † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Malignant neoplasm progression † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Metastases to bone † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Metastases to central nervous system † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Metastases to spleen † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Oncologic complication † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Transitional cell carcinoma † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Tumour haemorrhage † 1  2/45 (4.44%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Tumour pain † 1  1/45 (2.22%)  1/45 (2.22%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Nervous system disorders                               
Cerebral haemorrhage † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Diabetic hyperglycaemic coma † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Dizziness † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Epilepsy † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Facial paresis † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Haemorrhage intracranial † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Headache † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hemiparesis † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hypoglossal nerve disorder † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Nervous system disorder † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Peripheral nerve paresis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Seizure † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Spinal cord compression † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Product Issues                               
Device dislocation † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Renal and urinary disorders                               
Acute kidney injury † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Renal failure † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  1/42 (2.38%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Reproductive system and breast disorders                               
Pelvic pain † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Respiratory, thoracic and mediastinal disorders                               
Acute respiratory failure † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Chronic obstructive pulmonary disease † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Dyspnoea † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Haemothorax † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pleural effusion † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pulmonary embolism † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Skin and subcutaneous tissue disorders                               
Rash † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Vascular disorders                               
Deep vein thrombosis † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Hypotension † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Peripheral ischaemia † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Phlebitis † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Vena cava thrombosis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Venous thrombosis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
1
Term from vocabulary, MedDRA (25.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/45 (88.89%)   5/45 (11.11%)   0/0   42/43 (97.67%)   6/43 (13.95%)   0/0   32/42 (76.19%)   5/42 (11.90%)   0/0   44/44 (100.00%)   9/44 (20.45%)   0/0   18/21 (85.71%)   2/21 (9.52%)   0/0 
Blood and lymphatic system disorders                               
Anaemia † 1  3/45 (6.67%)  2/45 (4.44%)  /0  6/43 (13.95%)  1/43 (2.33%)  /0  6/42 (14.29%)  1/42 (2.38%)  /0  11/44 (25.00%)  0/44 (0.00%)  /0  3/21 (14.29%)  1/21 (4.76%)  /0 
Eosinophilia † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Leukopenia † 1  2/45 (4.44%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  1/42 (2.38%)  /0  4/44 (9.09%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Lymphopenia † 1  2/45 (4.44%)  1/45 (2.22%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  7/44 (15.91%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Neutropenia † 1  3/45 (6.67%)  1/45 (2.22%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  20/44 (45.45%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Thrombocytopenia † 1  1/45 (2.22%)  1/45 (2.22%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Endocrine disorders                               
Hypothyroidism † 1  2/45 (4.44%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Gastrointestinal disorders                               
Abdominal pain † 1  5/45 (11.11%)  1/45 (2.22%)  /0  3/43 (6.98%)  0/43 (0.00%)  /0  5/42 (11.90%)  0/42 (0.00%)  /0  5/44 (11.36%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Constipation † 1  8/45 (17.78%)  0/45 (0.00%)  /0  6/43 (13.95%)  1/43 (2.33%)  /0  7/42 (16.67%)  0/42 (0.00%)  /0  3/44 (6.82%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Diarrhoea † 1  6/45 (13.33%)  0/45 (0.00%)  /0  10/43 (23.26%)  1/43 (2.33%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  9/44 (20.45%)  1/44 (2.27%)  /0  5/21 (23.81%)  0/21 (0.00%)  /0 
Dry mouth † 1  3/45 (6.67%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  4/42 (9.52%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Nausea † 1  13/45 (28.89%)  0/45 (0.00%)  /0  18/43 (41.86%)  0/43 (0.00%)  /0  9/42 (21.43%)  1/42 (2.38%)  /0  15/44 (34.09%)  2/44 (4.55%)  /0  6/21 (28.57%)  0/21 (0.00%)  /0 
Vomiting † 1  6/45 (13.33%)  0/45 (0.00%)  /0  11/43 (25.58%)  0/43 (0.00%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  8/44 (18.18%)  1/44 (2.27%)  /0  3/21 (14.29%)  0/21 (0.00%)  /0 
General disorders                               
Asthenia † 1  9/45 (20.00%)  1/45 (2.22%)  /0  7/43 (16.28%)  1/43 (2.33%)  /0  7/42 (16.67%)  0/42 (0.00%)  /0  8/44 (18.18%)  2/44 (4.55%)  /0  7/21 (33.33%)  0/21 (0.00%)  /0 
Chest pain † 1  2/45 (4.44%)  0/45 (0.00%)  /0  3/43 (6.98%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Chills † 1  1/45 (2.22%)  0/45 (0.00%)  /0  3/43 (6.98%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Fatigue † 1  7/45 (15.56%)  1/45 (2.22%)  /0  5/43 (11.63%)  0/43 (0.00%)  /0  5/42 (11.90%)  1/42 (2.38%)  /0  8/44 (18.18%)  1/44 (2.27%)  /0  4/21 (19.05%)  0/21 (0.00%)  /0 
Oedema peripheral † 1  3/45 (6.67%)  0/45 (0.00%)  /0  10/43 (23.26%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Pain † 1  4/45 (8.89%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  2/44 (4.55%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pyrexia † 1  3/45 (6.67%)  0/45 (0.00%)  /0  13/43 (30.23%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  8/44 (18.18%)  2/44 (4.55%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Hepatobiliary disorders                               
Hepatic cytolysis † 1  0/45 (0.00%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Infections and infestations                               
Rhinitis † 1  3/45 (6.67%)  0/45 (0.00%)  /0  3/43 (6.98%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  1/44 (2.27%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Investigations                               
Alanine aminotransferase increased † 1  1/45 (2.22%)  0/45 (0.00%)  /0  6/43 (13.95%)  0/43 (0.00%)  /0  2/42 (4.76%)  1/42 (2.38%)  /0  15/44 (34.09%)  2/44 (4.55%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Amylase increased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  3/44 (6.82%)  1/44 (2.27%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Aspartate aminotransferase increased † 1  1/45 (2.22%)  0/45 (0.00%)  /0  5/43 (11.63%)  0/43 (0.00%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  17/44 (38.64%)  1/44 (2.27%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Blood alkaline phosphatase increased † 1  4/45 (8.89%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Blood creatinine increased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  5/43 (11.63%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  4/44 (9.09%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Blood lactate dehydrogenase increased † 1  3/45 (6.67%)  2/45 (4.44%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Blood potassium decreased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Electrocardiogram QT prolonged † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Gamma-glutamyltransferase increased † 1  2/45 (4.44%)  1/45 (2.22%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  3/44 (6.82%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Haemoglobin decreased † 1  1/45 (2.22%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  2/21 (9.52%)  1/21 (4.76%)  /0 
Lipase increased † 1  3/45 (6.67%)  1/45 (2.22%)  /0  3/43 (6.98%)  0/43 (0.00%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  5/44 (11.36%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Neutrophil count decreased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Platelet count decreased † 1  2/45 (4.44%)  0/45 (0.00%)  /0  3/43 (6.98%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
SARS-CoV-2 test negative † 1  0/45 (0.00%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  4/44 (9.09%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Weight decreased † 1  6/45 (13.33%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  5/42 (11.90%)  1/42 (2.38%)  /0  4/44 (9.09%)  2/44 (4.55%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
White blood cell count decreased † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  4/44 (9.09%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Metabolism and nutrition disorders                               
Decreased appetite † 1  10/45 (22.22%)  0/45 (0.00%)  /0  3/43 (6.98%)  1/43 (2.33%)  /0  7/42 (16.67%)  0/42 (0.00%)  /0  9/44 (20.45%)  2/44 (4.55%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Hypoalbuminaemia † 1  1/45 (2.22%)  0/45 (0.00%)  /0  3/43 (6.98%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  0/44 (0.00%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Musculoskeletal and connective tissue disorders                               
Arthralgia † 1  5/45 (11.11%)  1/45 (2.22%)  /0  2/43 (4.65%)  1/43 (2.33%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Back pain † 1  5/45 (11.11%)  0/45 (0.00%)  /0  4/43 (9.30%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  6/44 (13.64%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Pain in extremity † 1  5/45 (11.11%)  0/45 (0.00%)  /0  3/43 (6.98%)  2/43 (4.65%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  3/44 (6.82%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                               
Cancer pain † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  1/44 (2.27%)  1/44 (2.27%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Tumour pain † 1  2/45 (4.44%)  0/45 (0.00%)  /0  1/43 (2.33%)  1/43 (2.33%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Nervous system disorders                               
Dizziness † 1  3/45 (6.67%)  0/45 (0.00%)  /0  2/43 (4.65%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Headache † 1  3/45 (6.67%)  0/45 (0.00%)  /0  5/43 (11.63%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  4/44 (9.09%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Paraesthesia † 1  1/45 (2.22%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  1/42 (2.38%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Psychiatric disorders                               
Insomnia † 1  2/45 (4.44%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  1/42 (2.38%)  0/42 (0.00%)  /0  4/44 (9.09%)  0/44 (0.00%)  /0  1/21 (4.76%)  0/21 (0.00%)  /0 
Respiratory, thoracic and mediastinal disorders                               
Cough † 1  3/45 (6.67%)  0/45 (0.00%)  /0  8/43 (18.60%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  8/44 (18.18%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Dyspnoea † 1  1/45 (2.22%)  0/45 (0.00%)  /0  6/43 (13.95%)  0/43 (0.00%)  /0  8/42 (19.05%)  0/42 (0.00%)  /0  4/44 (9.09%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Skin and subcutaneous tissue disorders                               
Eczema † 1  0/45 (0.00%)  0/45 (0.00%)  /0  1/43 (2.33%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Pruritus † 1  11/45 (24.44%)  0/45 (0.00%)  /0  6/43 (13.95%)  0/43 (0.00%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  8/44 (18.18%)  1/44 (2.27%)  /0  3/21 (14.29%)  0/21 (0.00%)  /0 
Rash † 1  4/45 (8.89%)  0/45 (0.00%)  /0  8/43 (18.60%)  0/43 (0.00%)  /0  3/42 (7.14%)  0/42 (0.00%)  /0  4/44 (9.09%)  1/44 (2.27%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
Vitiligo † 1  4/45 (8.89%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  2/42 (4.76%)  0/42 (0.00%)  /0  2/44 (4.55%)  0/44 (0.00%)  /0  2/21 (9.52%)  0/21 (0.00%)  /0 
Vascular disorders                               
Hypertension † 1  1/45 (2.22%)  0/45 (0.00%)  /0  0/43 (0.00%)  0/43 (0.00%)  /0  0/42 (0.00%)  0/42 (0.00%)  /0  3/44 (6.82%)  0/44 (0.00%)  /0  0/21 (0.00%)  0/21 (0.00%)  /0 
1
Term from vocabulary, MedDRA (25.1)
†
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03484923    
Other Study ID Numbers: CPDR001J2201
2018-000610-38 ( EudraCT Number )
First Submitted: March 26, 2018
First Posted: April 2, 2018
Results First Submitted: December 20, 2023
Results First Posted: January 18, 2024
Last Update Posted: January 18, 2024