Trial Outcomes & Findings for Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) (NCT NCT03820986)
NCT ID: NCT03820986
Last Updated: 2026-02-09
Results Overview
PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
674 participants
Primary outcome timeframe
Up to approximately 34 months
Results posted on
2026-02-09
Participant Flow
Adult participants with advanced melanoma, who have not received prior systemic therapy were enrolled. 674 participants were randomly assigned in a 1:1 ratio to either combination therapy, Pembrolizumab+Lenvatinib, or Pembrolizumab+Placebo, to assess the safety and efficacy of combination therapy, Pembrolizumab+Lenvatinib.
Participant milestones
| Measure |
Pembrolizumab+Lenvatinib
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Placebo
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Overall Study
STARTED
|
334
|
340
|
|
Overall Study
Treated
|
332
|
338
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
334
|
340
|
Reasons for withdrawal
| Measure |
Pembrolizumab+Lenvatinib
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Placebo
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Overall Study
Death
|
201
|
175
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
122
|
160
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
Baseline Characteristics
Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)
Baseline characteristics by cohort
| Measure |
Pembrolizumab+Lenvatinib
n=334 Participants
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Placebo
n=340 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Total
n=674 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 14.0 • n=362 Participants
|
62.0 Years
STANDARD_DEVIATION 13.1 • n=3 Participants
|
61.9 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=362 Participants
|
139 Participants
n=3 Participants
|
264 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=362 Participants
|
201 Participants
n=3 Participants
|
410 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=362 Participants
|
79 Participants
n=3 Participants
|
149 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=362 Participants
|
225 Participants
n=3 Participants
|
449 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=362 Participants
|
36 Participants
n=3 Participants
|
76 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
55 Participants
n=362 Participants
|
43 Participants
n=3 Participants
|
98 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=362 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
243 Participants
n=362 Participants
|
261 Participants
n=3 Participants
|
504 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=362 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=362 Participants
|
31 Participants
n=3 Participants
|
65 Participants
n=7 Participants
|
|
Proto-oncogene B-Raf (BRAF) mutation positive
No
|
211 Participants
n=362 Participants
|
215 Participants
n=3 Participants
|
426 Participants
n=7 Participants
|
|
Proto-oncogene B-Raf (BRAF) mutation positive
Yes
|
123 Participants
n=362 Participants
|
125 Participants
n=3 Participants
|
248 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 34 monthsPopulation: All randomized participants, included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=340 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=334 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
4.2 Months
Interval 3.1 to 6.3
|
9.1 Months
Interval 6.4 to 11.8
|
PRIMARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants, included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
OS is defined as the time from date of randomization to date of death from any cause. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=340 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=334 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Overall Survival (OS)
|
39.5 Months
Interval 26.6 to
NA=upper limit not reached
|
25.8 Months
Interval 23.0 to 33.9
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants, included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=340 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=334 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR Per RECIST 1.1
|
35.6 Percentage of participants
Interval 30.5 to 40.9
|
43.4 Percentage of participants
Interval 38.0 to 48.9
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: Randomized participants who had a confirmed complete or partial response, included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.
For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the date of the first documented evidence of CR or PR until disease progression or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=121 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=145 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1
|
NA Months
NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
26.9 Months
Interval 3.4 to
NA=upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 67 monthsPopulation: All randomized participants who received at least one dose of study intervention. The final analysis for this outcome is presented here.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=338 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=332 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
330 Participants
|
331 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 63 monthsPopulation: All randomized participants who received at least one dose of study intervention. The final analysis for this outcome is presented here.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued any study treatment due to an AE is presented. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=338 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=332 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs)
|
68 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 21Population: All randomized participants who had at least 1 assessment available for the EORTC QLQ-C30 GHS/QoL score and had received at least 1 dose of study intervention. The final analysis for this outcome is presented here.
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The GHS/QoL combined score consists of participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" GHS/QoL responses range in score from 0 to 100, with a higher score indicating a better outcome. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=334 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=325 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Global Health Status (GHS)/Quality of Life (QoL) Score
|
-2.69 Scores on a scale
Interval -5.3 to -0.08
|
-6.38 Scores on a scale
Interval -8.91 to -3.84
|
SECONDARY outcome
Timeframe: Baseline and Week 21Population: All randomized participants who had at least 1 assessment available for the EORTC QLQ-C30 PF score and had received at least 1 dose of study intervention. The final analysis for this outcome is presented here.
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The PF Score consists of participant responses to questions regarding PF (5 questions about daily activities \[strenuous activities, long walks, short walks, bed/chair rest and needing help with eating, dressing, washing themselves or using the toilet\]). For PF, responses range in score from 0 to 100, with a higher score indicating a better outcome. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=334 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=325 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Physical Function (PF) Score
|
-4.02 Scores on a scale
Interval -6.23 to -1.8
|
-9.50 Scores on a scale
Interval -11.66 to -7.34
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for EORTC QLQ-C30 and have received at least one dose of the study intervention; and had data available for this TTD change from baseline in GHS/QoL outcome using EORTC QLQ-C30. The final analysis for this outcome is presented here.
TTD is defined as the time from Baseline to 1st onset of a ≥10-point negative change (decrease) in EORTC-QLQ-C30 GHS Score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The GHS/QoL Score consists of participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" GHS/QoL responses range in score from 0 to 100, with a higher score indicating a better outcome. A longer TTD indicates a better outcome. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=323 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=305 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 GHS/QoL Score
|
24.58 Months
Interval 11.04 to
NA=not reached
|
5.62 Months
Interval 4.34 to 9.69
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: Per protocol, the analysis population consisted of all randomized participants who have at least one assessment available for EORTC QLQ-C30 and have received at least one dose of the study intervention; and had data available for this TTD change from baseline in PF Score outcome using EORTC QLQ-C30. The final analysis for this outcome is presented here.
TTD is defined as the time from Baseline to 1st onset of a ≥10-point negative change (decrease) in EORTC-QLQ-C30 PF Score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The PF Score consists of participant responses to questions regarding PF (5 questions about daily activities \[strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves or using the toilet\]. For PF, responses range in score from 0 to 100, with a higher score indicating a better outcome. The final analysis for this outcome is presented here.
Outcome measures
| Measure |
Pembrolizumab+Placebo
n=323 Participants
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Lenvatinib
n=305 Participants
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 in Physical Function (PF) Score
|
NA Months
NA=not reached
|
5.55 Months
Interval 4.4 to 9.69
|
Adverse Events
Pembrolizumab+Lenvatinib
Serious events: 124 serious events
Other events: 326 other events
Deaths: 206 deaths
Pembrolizumab+Placebo
Serious events: 96 serious events
Other events: 319 other events
Deaths: 176 deaths
Serious adverse events
| Measure |
Pembrolizumab+Lenvatinib
n=332 participants at risk
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Placebo
n=338 participants at risk
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
4/332 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial flutter
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Addison's disease
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.90%
3/332 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Uveitis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Anal fistula
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.90%
3/332 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
6/332 • Number of events 7 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
4/338 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Enteritis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
4/332 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.89%
3/338 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Death
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Gait disturbance
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
General physical health deterioration
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pain
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
1.2%
4/332 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.90%
3/332 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.90%
3/332 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Abdominal abscess
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Abdominal sepsis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Anal abscess
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Appendicitis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.5%
5/338 • Number of events 5 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.90%
3/332 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.8%
6/338 • Number of events 6 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.90%
3/332 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Encephalitis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Enteritis infectious
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Escherichia sepsis
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Haemophilus infection
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infection
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
1.5%
5/332 • Number of events 5 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia aspiration
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Postoperative wound infection
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pyelonephritis acute
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Rectal abscess
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Skin candida
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Tick-borne fever
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Wound infection
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Vascular access site inflammation
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Amylase increased
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Lipase increased
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Troponin T increased
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.90%
3/332 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage I
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.89%
3/338 • Number of events 6 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Amnesia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Hemiparesis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Seizure
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Delirium
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Depression
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
4/332 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.89%
3/338 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.30%
1/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Prerenal failure
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.89%
3/338 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
5/332 • Number of events 5 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/332 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.59%
2/338 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
0.90%
3/332 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypovolaemic shock
|
0.60%
2/332 • Number of events 2 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/338 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/332 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.30%
1/338 • Number of events 1 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab+Lenvatinib
n=332 participants at risk
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.
|
Pembrolizumab+Placebo
n=338 participants at risk
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
17.5%
58/332 • Number of events 96 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
40/338 • Number of events 45 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.0%
40/332 • Number of events 58 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.7%
53/338 • Number of events 70 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.5%
25/332 • Number of events 43 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.4%
8/338 • Number of events 16 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.3%
21/332 • Number of events 32 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.8%
6/338 • Number of events 6 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
13.3%
44/332 • Number of events 48 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
17/338 • Number of events 18 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
47.3%
157/332 • Number of events 198 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.0%
44/338 • Number of events 50 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.2%
47/332 • Number of events 58 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.6%
19/338 • Number of events 22 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
17.8%
59/332 • Number of events 90 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
14.8%
50/338 • Number of events 60 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
51.5%
171/332 • Number of events 454 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
24.9%
84/338 • Number of events 141 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
10.8%
36/332 • Number of events 39 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.8%
23/338 • Number of events 26 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
31/332 • Number of events 39 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.6%
12/338 • Number of events 13 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
33.4%
111/332 • Number of events 204 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
18.0%
61/338 • Number of events 85 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
9.0%
30/332 • Number of events 43 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
4/338 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
22.6%
75/332 • Number of events 134 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.2%
38/338 • Number of events 51 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
28.6%
95/332 • Number of events 164 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
24.3%
82/338 • Number of events 122 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
27.7%
92/332 • Number of events 130 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.4%
86/338 • Number of events 109 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
11.7%
39/332 • Number of events 54 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.0%
10/338 • Number of events 12 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
11.7%
39/332 • Number of events 43 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.1%
34/338 • Number of events 43 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
12.0%
40/332 • Number of events 50 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.4%
42/338 • Number of events 60 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
6.3%
21/332 • Number of events 21 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.3%
28/338 • Number of events 33 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
8.4%
28/332 • Number of events 39 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.4%
35/338 • Number of events 44 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
22.6%
75/332 • Number of events 118 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.3%
55/338 • Number of events 89 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Amylase increased
|
14.2%
47/332 • Number of events 73 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.9%
37/338 • Number of events 72 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
24.7%
82/332 • Number of events 130 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.9%
47/338 • Number of events 67 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.2%
34/332 • Number of events 52 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.1%
24/338 • Number of events 30 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
12.0%
40/332 • Number of events 81 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.6%
19/338 • Number of events 34 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood cholesterol increased
|
10.8%
36/332 • Number of events 77 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.8%
13/338 • Number of events 27 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.8%
49/332 • Number of events 77 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.1%
41/338 • Number of events 73 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
12.7%
42/332 • Number of events 73 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.7%
26/338 • Number of events 48 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood glucose increased
|
5.4%
18/332 • Number of events 40 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.7%
16/338 • Number of events 28 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.9%
33/332 • Number of events 63 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.2%
21/338 • Number of events 28 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood sodium decreased
|
6.3%
21/332 • Number of events 46 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.0%
10/338 • Number of events 19 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
16.9%
56/332 • Number of events 79 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.3%
18/338 • Number of events 36 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood triglycerides increased
|
9.3%
31/332 • Number of events 67 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.5%
22/338 • Number of events 43 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood urea increased
|
6.3%
21/332 • Number of events 38 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.1%
14/338 • Number of events 43 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.8%
36/332 • Number of events 49 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.8%
23/338 • Number of events 30 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Lipase increased
|
25.6%
85/332 • Number of events 171 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
18.0%
61/338 • Number of events 115 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
7.8%
26/332 • Number of events 42 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.89%
3/338 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
27.4%
91/332 • Number of events 111 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.9%
30/338 • Number of events 36 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.0%
113/332 • Number of events 166 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.0%
54/338 • Number of events 58 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
10.5%
35/332 • Number of events 64 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.3%
18/338 • Number of events 27 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.7%
52/332 • Number of events 92 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.5%
39/338 • Number of events 62 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
17.8%
59/332 • Number of events 118 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.3%
28/338 • Number of events 49 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.1%
17/332 • Number of events 29 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.7%
9/338 • Number of events 16 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.3%
21/332 • Number of events 33 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.4%
8/338 • Number of events 9 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
37/332 • Number of events 51 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.7%
16/338 • Number of events 23 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.0%
20/332 • Number of events 27 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.7%
9/338 • Number of events 13 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
37/332 • Number of events 57 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.9%
20/338 • Number of events 26 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.1%
100/332 • Number of events 162 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.4%
69/338 • Number of events 100 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.3%
64/332 • Number of events 78 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.4%
42/338 • Number of events 56 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.0%
63/332 • Number of events 76 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.4%
42/338 • Number of events 52 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.3%
31/332 • Number of events 37 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.5%
32/338 • Number of events 38 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
12.0%
40/332 • Number of events 54 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.0%
27/338 • Number of events 29 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
6.9%
23/332 • Number of events 32 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.5%
5/338 • Number of events 6 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
22.9%
76/332 • Number of events 131 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.1%
51/338 • Number of events 59 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
7.5%
25/332 • Number of events 29 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.6%
29/338 • Number of events 30 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Proteinuria
|
30.1%
100/332 • Number of events 177 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.4%
35/338 • Number of events 61 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
43/332 • Number of events 51 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.1%
41/338 • Number of events 54 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.3%
54/332 • Number of events 61 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.89%
3/338 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.5%
25/332 • Number of events 30 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.4%
25/338 • Number of events 27 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.7%
19/332 • Number of events 20 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.89%
3/338 • Number of events 3 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
18/332 • Number of events 22 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
4/338 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.3%
21/332 • Number of events 23 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.6%
12/338 • Number of events 12 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
15.7%
52/332 • Number of events 71 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
4/338 • Number of events 4 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.5%
68/332 • Number of events 81 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.1%
78/338 • Number of events 114 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.7%
62/332 • Number of events 89 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.9%
57/338 • Number of events 75 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
6.3%
21/332 • Number of events 23 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.1%
41/338 • Number of events 41 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
61.1%
203/332 • Number of events 378 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
22.2%
75/338 • Number of events 119 • Up to approximately 67 months
All-cause mortality includes all randomized participants included into treatment group they were randomized. Serious AEs \& other AEs: includes all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER