Trial Outcomes & Findings for Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811) (NCT NCT03615326)
NCT ID: NCT03615326
Last Updated: 2025-12-11
Results Overview
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
738 participants
Primary outcome timeframe
Up to 46 months
Results posted on
2025-12-11
Participant Flow
Per protocol, response or progression for participants in the Japan-specific SOX (S-1 plus oxaliplatin) Cohort and for participants in the second course of pembrolizumab were not counted towards efficacy analysis, and adverse events for participants during the second course of pembrolizumab were not counted towards safety analysis.
Participant milestones
| Measure |
Global Pembrolizumab + Standard of Care First Course
Participants received 200 mg pembrolizumab intravenously (IV) every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with cisplatin plus 5-fluorouracil (FP) or capecitabine/oxaliplatin (CAPOX) chemotherapy. Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
|
Global Standard of Care
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
350
|
348
|
20
|
20
|
|
Overall Study
Treated
|
350
|
346
|
20
|
20
|
|
Overall Study
Received Second Course of Pembrolizumab
|
11
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
350
|
348
|
20
|
20
|
Reasons for withdrawal
| Measure |
Global Pembrolizumab + Standard of Care First Course
Participants received 200 mg pembrolizumab intravenously (IV) every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with cisplatin plus 5-fluorouracil (FP) or capecitabine/oxaliplatin (CAPOX) chemotherapy. Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
|
Global Standard of Care
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Overall Study
Death
|
266
|
286
|
14
|
17
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
|
Overall Study
Participants Ongoing
|
83
|
58
|
6
|
3
|
Baseline Characteristics
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
Baseline characteristics by cohort
| Measure |
Japan Trastuzumab + S-1 Plus Oxaliplatin
n=20 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Global Pembrolizumab + Standard of Care First Course
n=350 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy. Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
|
Global Standard of Care
n=348 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
n=20 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Total
n=738 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.1 Years
STANDARD_DEVIATION 6.8 • n=639 Participants
|
60.4 Years
STANDARD_DEVIATION 11.8 • n=237 Participants
|
61.7 Years
STANDARD_DEVIATION 10.8 • n=243 Participants
|
66.1 Years
STANDARD_DEVIATION 12.8 • n=480 Participants
|
61.2 Years
STANDARD_DEVIATION 11.3 • n=277 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=639 Participants
|
66 Participants
n=237 Participants
|
68 Participants
n=243 Participants
|
3 Participants
n=480 Participants
|
142 Participants
n=277 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=639 Participants
|
284 Participants
n=237 Participants
|
280 Participants
n=243 Participants
|
17 Participants
n=480 Participants
|
596 Participants
n=277 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=639 Participants
|
38 Participants
n=237 Participants
|
45 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
85 Participants
n=277 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=639 Participants
|
309 Participants
n=237 Participants
|
293 Participants
n=243 Participants
|
19 Participants
n=480 Participants
|
640 Participants
n=277 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=639 Participants
|
3 Participants
n=237 Participants
|
10 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
13 Participants
n=277 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=639 Participants
|
5 Participants
n=237 Participants
|
6 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
11 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=639 Participants
|
119 Participants
n=237 Participants
|
121 Participants
n=243 Participants
|
20 Participants
n=480 Participants
|
280 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=639 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=639 Participants
|
2 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
4 Participants
n=277 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=639 Participants
|
218 Participants
n=237 Participants
|
212 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
430 Participants
n=277 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=639 Participants
|
6 Participants
n=237 Participants
|
5 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
11 Participants
n=277 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=639 Participants
|
0 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
2 Participants
n=277 Participants
|
|
Geographic Region
Western Europe/Israel/North America/Australia
|
0 Participants
n=639 Participants
|
113 Participants
n=237 Participants
|
111 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
224 Participants
n=277 Participants
|
|
Geographic Region
Asia
|
0 Participants
n=639 Participants
|
118 Participants
n=237 Participants
|
119 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
237 Participants
n=277 Participants
|
|
Geographic Region
Rest of the World
|
0 Participants
n=639 Participants
|
119 Participants
n=237 Participants
|
118 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
237 Participants
n=277 Participants
|
|
Geographic Region
Japan
|
20 Participants
n=639 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
20 Participants
n=480 Participants
|
40 Participants
n=277 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status at Baseline
CPS≥1
|
17 Participants
n=639 Participants
|
298 Participants
n=237 Participants
|
296 Participants
n=243 Participants
|
16 Participants
n=480 Participants
|
627 Participants
n=277 Participants
|
|
Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status at Baseline
CPS<1
|
3 Participants
n=639 Participants
|
52 Participants
n=237 Participants
|
52 Participants
n=243 Participants
|
4 Participants
n=480 Participants
|
111 Participants
n=277 Participants
|
|
Chemotherapy Regimen
FP (cisplatin plus 5 fluorouracil)
|
0 Participants
n=639 Participants
|
53 Participants
n=237 Participants
|
49 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
102 Participants
n=277 Participants
|
|
Chemotherapy Regimen
CAPOX (capecitabine and oxaliplatin)
|
0 Participants
n=639 Participants
|
297 Participants
n=237 Participants
|
299 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
596 Participants
n=277 Participants
|
|
Chemotherapy Regimen
SOX (S-1 plus oxaliplatin)
|
20 Participants
n=639 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
20 Participants
n=480 Participants
|
40 Participants
n=277 Participants
|
PRIMARY outcome
Timeframe: Up to 46 monthsPopulation: All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Outcome measures
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=350 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=348 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR
|
10.0 Months
Interval 8.6 to 12.2
|
8.1 Months
Interval 7.0 to 8.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 63 monthsPopulation: All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
OS is defined as the time from randomization to death due to any cause. OS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Outcome measures
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=350 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=348 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
20.0 Months
Interval 17.8 to 22.1
|
16.8 Months
Interval 14.9 to 18.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 63 monthsPopulation: All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Outcome measures
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=350 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=348 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR
|
72.6 Percentage of Participants
Interval 67.6 to 77.2
|
60.1 Percentage of Participants
Interval 54.7 to 65.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 63 monthsPopulation: All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm and who had CR or PR per RECIST 1.1 as assessed by BICR were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Outcome measures
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=254 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=209 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Duration of Response (DOR) Per RECIST 1.1 Assessed by BICR
|
11.13 Months
Interval 9.8 to 12.7
|
9.5 Months
Interval 7.2 to 11.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 63 monthsPopulation: All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
Outcome measures
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=350 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=346 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
n=20 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
n=20 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
348 Participants
|
346 Participants
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to 63 monthsPopulation: All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study treatment due to an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
Outcome measures
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=350 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=346 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
n=20 Participants
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
n=20 Participants
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to AEs
|
150 Participants
|
136 Participants
|
11 Participants
|
11 Participants
|
Adverse Events
Global Pembrolizumab + Standard of Care First Course
Serious events: 163 serious events
Other events: 345 other events
Deaths: 264 deaths
Global Standard of Care
Serious events: 159 serious events
Other events: 338 other events
Deaths: 288 deaths
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
Serious events: 10 serious events
Other events: 20 other events
Deaths: 14 deaths
Japan Trastuzumab + S-1 Plus Oxaliplatin
Serious events: 9 serious events
Other events: 20 other events
Deaths: 17 deaths
Global Pembrolizumab + Standard of Care Second Course
Serious events: 0 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=350 participants at risk
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=346 participants at risk
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
n=20 participants at risk
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
n=20 participants at risk
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Global Pembrolizumab + Standard of Care Second Course
n=11 participants at risk
Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
5/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.7%
6/346 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Arrhythmia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Atrial fibrillation
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Cardiac failure
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Endocrine disorders
Hypophysitis
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Endocrine disorders
Hypopituitarism
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Endocrine disorders
Hypothyroidism
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Eye disorders
Dry eye
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
4/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Constipation
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
17/350 • Number of events 19 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.6%
16/346 • Number of events 17 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
6/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.0%
7/346 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Enteritis
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
1.1%
4/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.7%
6/346 • Number of events 10 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
6/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Haematemesis
|
0.86%
3/350 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
4/350 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.2%
4/346 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Oesophageal fibrosis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Oesophageal stent stenosis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Stomatitis
|
0.86%
3/350 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.7%
6/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.4%
5/346 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
7/350 • Number of events 9 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.6%
9/346 • Number of events 9 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Asthenia
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Chest pain
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Death
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Fatigue
|
1.4%
5/350 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
General physical health deterioration
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Mucosal inflammation
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Pyrexia
|
1.1%
4/350 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.7%
6/346 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Sudden death
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Hepatitis
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Liver disorder
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Immune system disorders
Anaphylactic reaction
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Abdominal infection
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Anal abscess
|
0.29%
1/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Biliary tract infection
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Bronchitis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
COVID-19
|
1.1%
4/350 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.4%
5/346 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Cellulitis
|
0.29%
1/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Fungal oesophagitis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Herpes zoster
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Infection
|
0.29%
1/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Infection in an immunocompromised host
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Infectious pleural effusion
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Influenza
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Injection site cellulitis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Neutropenic sepsis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Osteomyelitis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Peritonitis
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Pneumonia
|
5.4%
19/350 • Number of events 20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.6%
9/346 • Number of events 10 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Pneumonia aspiration
|
0.86%
3/350 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Sepsis
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Wound infection
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.0%
7/350 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Stoma site discharge
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Transcription medication error
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Alanine aminotransferase increased
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Aspartate aminotransferase increased
|
0.86%
3/350 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Blood bilirubin increased
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Blood glucose increased
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Cortisol decreased
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Ejection fraction decreased
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Platelet count decreased
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.7%
6/346 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.2%
4/346 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.2%
4/346 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.29%
1/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.7%
6/346 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer fatigue
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Cerebral infarction
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Headache
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Psychogenic seizure
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Seizure
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Product Issues
Device dislocation
|
0.57%
2/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Product Issues
Device failure
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Product Issues
Device occlusion
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Psychiatric disorders
Alcohol abuse
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Psychiatric disorders
Confusional state
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Psychiatric disorders
Delirium
|
0.29%
1/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
6/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Nephritis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Prerenal failure
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
8/350 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
10/350 • Number of events 10 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.0%
7/346 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Vascular disorders
Thrombosis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Vascular disorders
Vena cava thrombosis
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
Other adverse events
| Measure |
Global Pembrolizumab + Standard of Care First Course
n=350 participants at risk
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Global Standard of Care
n=346 participants at risk
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
|
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
n=20 participants at risk
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Japan Trastuzumab + S-1 Plus Oxaliplatin
n=20 participants at risk
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
|
Global Pembrolizumab + Standard of Care Second Course
n=11 participants at risk
Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
44.9%
157/350 • Number of events 269 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
46.0%
159/346 • Number of events 257 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
25.0%
5/20 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
18.2%
2/11 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
12/350 • Number of events 26 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
6.6%
23/346 • Number of events 46 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.9%
59/350 • Number of events 133 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
16.5%
57/346 • Number of events 111 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.3%
43/350 • Number of events 67 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
12.4%
43/346 • Number of events 71 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Endocrine disorders
Hypothyroidism
|
10.3%
36/350 • Number of events 42 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.6%
16/346 • Number of events 22 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
42/350 • Number of events 48 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
11.8%
41/346 • Number of events 63 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
23/350 • Number of events 25 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
7.8%
27/346 • Number of events 30 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Constipation
|
17.7%
62/350 • Number of events 80 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
19.7%
68/346 • Number of events 81 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
40.0%
8/20 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
25.0%
5/20 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.6%
177/350 • Number of events 330 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
43.9%
152/346 • Number of events 295 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
60.0%
12/20 • Number of events 30 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
60.0%
12/20 • Number of events 25 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
24/350 • Number of events 27 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.9%
17/346 • Number of events 17 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Dysphagia
|
6.9%
24/350 • Number of events 31 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
6.6%
23/346 • Number of events 23 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
5/350 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Nausea
|
47.7%
167/350 • Number of events 339 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
47.4%
164/346 • Number of events 323 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
45.0%
9/20 • Number of events 12 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
55.0%
11/20 • Number of events 15 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
18.2%
2/11 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
39/350 • Number of events 61 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
8.7%
30/346 • Number of events 39 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
40.0%
8/20 • Number of events 12 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Gastrointestinal disorders
Vomiting
|
32.6%
114/350 • Number of events 199 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
26.6%
92/346 • Number of events 163 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
45.0%
9/20 • Number of events 13 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
25.0%
5/20 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Asthenia
|
14.3%
50/350 • Number of events 90 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
18.8%
65/346 • Number of events 112 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Fatigue
|
22.3%
78/350 • Number of events 113 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
21.7%
75/346 • Number of events 96 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
25.0%
5/20 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
15.0%
3/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Malaise
|
8.9%
31/350 • Number of events 41 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
7.5%
26/346 • Number of events 32 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
25.0%
5/20 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
30.0%
6/20 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Mucosal inflammation
|
7.7%
27/350 • Number of events 37 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
7.5%
26/346 • Number of events 35 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Oedema peripheral
|
8.9%
31/350 • Number of events 37 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
7.8%
27/346 • Number of events 32 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
General disorders
Pyrexia
|
15.1%
53/350 • Number of events 80 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
12.1%
42/346 • Number of events 59 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
30.0%
6/20 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.1%
4/350 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.7%
6/346 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Hepatobiliary disorders
Liver disorder
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Immune system disorders
Drug hypersensitivity
|
1.4%
5/350 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.87%
3/346 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
27.3%
3/11 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Immune system disorders
Hypersensitivity
|
2.9%
10/350 • Number of events 14 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
1.7%
6/346 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
COVID-19
|
6.9%
24/350 • Number of events 28 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.9%
10/346 • Number of events 10 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
11/350 • Number of events 13 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Pneumonia
|
6.0%
21/350 • Number of events 23 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.6%
9/346 • Number of events 11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
9/350 • Number of events 9 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
3.2%
11/346 • Number of events 14 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.3%
36/350 • Number of events 44 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.5%
33/346 • Number of events 37 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
15.0%
3/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
65/350 • Number of events 92 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
13.6%
47/346 • Number of events 80 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Aspartate aminotransferase increased
|
24.3%
85/350 • Number of events 136 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
18.2%
63/346 • Number of events 108 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
18.2%
2/11 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.1%
18/350 • Number of events 20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
6.4%
22/346 • Number of events 34 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Blood bilirubin increased
|
14.6%
51/350 • Number of events 105 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.5%
33/346 • Number of events 81 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
15.0%
3/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Blood creatinine increased
|
8.6%
30/350 • Number of events 43 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.0%
14/346 • Number of events 18 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Lymphocyte count decreased
|
4.6%
16/350 • Number of events 21 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
3.8%
13/346 • Number of events 33 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Neutrophil count decreased
|
28.0%
98/350 • Number of events 258 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
24.6%
85/346 • Number of events 297 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
70.0%
14/20 • Number of events 29 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
55.0%
11/20 • Number of events 27 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Platelet count decreased
|
27.4%
96/350 • Number of events 216 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
28.0%
97/346 • Number of events 216 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
35.0%
7/20 • Number of events 9 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
40.0%
8/20 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
Weight decreased
|
21.4%
75/350 • Number of events 88 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
18.5%
64/346 • Number of events 72 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
25.0%
5/20 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Investigations
White blood cell count decreased
|
15.7%
55/350 • Number of events 146 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
12.1%
42/346 • Number of events 162 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
15.0%
3/20 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
15.0%
3/20 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.7%
111/350 • Number of events 169 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
31.8%
110/346 • Number of events 147 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
60.0%
12/20 • Number of events 17 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
30.0%
6/20 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.6%
23/350 • Number of events 39 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
6.1%
21/346 • Number of events 31 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
15.4%
54/350 • Number of events 90 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
16.5%
57/346 • Number of events 93 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.0%
21/350 • Number of events 26 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.5%
19/346 • Number of events 29 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.1%
53/350 • Number of events 87 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
11.3%
39/346 • Number of events 62 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.9%
24/350 • Number of events 31 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.0%
14/346 • Number of events 18 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.6%
23/350 • Number of events 27 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
7.5%
26/346 • Number of events 33 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.0%
14/350 • Number of events 18 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.3%
15/346 • Number of events 21 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.7%
6/350 • Number of events 6 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
25/350 • Number of events 35 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.6%
16/346 • Number of events 17 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
22/350 • Number of events 23 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
6.4%
22/346 • Number of events 25 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Dizziness
|
5.7%
20/350 • Number of events 23 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
3.5%
12/346 • Number of events 16 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Dysgeusia
|
4.9%
17/350 • Number of events 18 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.6%
16/346 • Number of events 17 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
45.0%
9/20 • Number of events 10 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Headache
|
6.3%
22/350 • Number of events 25 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
6.1%
21/346 • Number of events 25 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Neuropathy peripheral
|
18.6%
65/350 • Number of events 80 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
18.8%
65/346 • Number of events 88 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Paraesthesia
|
8.0%
28/350 • Number of events 49 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
6.6%
23/346 • Number of events 28 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
24.3%
85/350 • Number of events 119 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
21.1%
73/346 • Number of events 89 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
70.0%
14/20 • Number of events 21 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
70.0%
14/20 • Number of events 17 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Psychiatric disorders
Insomnia
|
6.3%
22/350 • Number of events 24 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.6%
16/346 • Number of events 17 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
15.0%
3/20 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Renal impairment
|
0.29%
1/350 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.58%
2/346 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
31/350 • Number of events 36 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.8%
20/346 • Number of events 20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
|
0.57%
2/350 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.29%
1/346 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
17/350 • Number of events 21 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
3.5%
12/346 • Number of events 15 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
14/350 • Number of events 23 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
3.5%
12/346 • Number of events 13 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.4%
19/350 • Number of events 24 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.9%
10/346 • Number of events 12 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
15.0%
3/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
23/350 • Number of events 25 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.3%
15/346 • Number of events 15 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.86%
3/350 • Number of events 3 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
23.1%
81/350 • Number of events 98 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
22.5%
78/346 • Number of events 93 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 5 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.9%
31/350 • Number of events 35 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.8%
20/346 • Number of events 20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
20.0%
4/20 • Number of events 4 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.6%
30/350 • Number of events 33 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.3%
15/346 • Number of events 18 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
25.0%
5/20 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.0%
7/350 • Number of events 7 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
2.3%
8/346 • Number of events 8 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
5.0%
1/20 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/350 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/346 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
9.1%
1/11 • Number of events 1 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
|
Vascular disorders
Hypertension
|
5.7%
20/350 • Number of events 35 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
4.9%
17/346 • Number of events 20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/20 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
10.0%
2/20 • Number of events 2 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
0.00%
0/11 • Up to 63 months
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
|
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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER