Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28) (NCT NCT02054806)
NCT ID: NCT02054806
Last Updated: 2023-10-30
Results Overview
Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
477 participants
Primary outcome timeframe
Up to approximately 86 months
Results posted on
2023-10-30
Participant Flow
Participants with a histologically- or cytologically-confirmed diagnosis of 20 advanced (unresectable and/or metastatic) solid tumors, were recruited into a single arm.
Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively. Per protocol, analyses of disease type cohort was planned and conducted for efficacy outcome measures only.
Participant milestones
| Measure |
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study.
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|---|---|
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Overall Study
STARTED
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477
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Overall Study
Treated During First Course
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475
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Overall Study
Treated During Second Course
|
11
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Overall Study
COMPLETED
|
0
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Overall Study
NOT COMPLETED
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477
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Reasons for withdrawal
| Measure |
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study.
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|---|---|
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Overall Study
Sponsor Decision
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31
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Overall Study
Withdrawal by Subject
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43
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Overall Study
Protocol Violation
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2
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Overall Study
Lost to Follow-up
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10
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Overall Study
Death
|
391
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Baseline Characteristics
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
Baseline characteristics by cohort
| Measure |
Pembrolizumab (MK-3475) 10 mg/kg
n=475 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study.
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|---|---|
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Age, Continuous
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58.7 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
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Sex: Female, Male
Female
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281 Participants
n=5 Participants
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Sex: Female, Male
Male
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
380 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
77 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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280 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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73 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to approximately 86 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.
Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.
Outcome measures
| Measure |
Cohort A1: Colon or Rectal Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
|
Cohort A2: Anal Canal Squamous Cell Carcinoma
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
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Cohort A3: Pancreas Adenocarcinoma
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.
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Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
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Cohort A5: Biliary Tract Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
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Cohort A6: Carcinoid Tumors
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
|
Cohort A7: Neuroendocrine Carcinomas
n=16 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
|
Cohort B1: ER Positive HER2 Negative Breast Cancer
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.
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Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
n=26 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
|
Cohort B3: Endometrial Carcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.
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Cohort B4: Cervical Squamous Cell Cancer
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.
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Cohort B5: Vulvar Squamous Cell Carcinoma
n=18 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
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Cohort C1: Small Cell Lung Cancer
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.
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Cohort C2: Mesothelioma
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).
|
Cohort D1: Thyroid Cancer
n=22 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).
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Cohort D2: Salivary Gland Carcinoma
n=26 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.
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Cohort D3: Nasopharyngeal Carcinoma
n=27 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.
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Cohort E1: Glioblastoma Multiforme
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.
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Cohort E2: Leiomyosarcoma
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.
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Cohort E3: Prostate Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.
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Overall Response Rate (ORR)
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4.3 Percentage of Participants
Interval 0.1 to 21.9
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20.0 Percentage of Participants
Interval 6.8 to 40.7
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0.0 Percentage of Participants
Interval 0.0 to 14.2
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30.4 Percentage of Participants
Interval 13.2 to 52.9
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17.4 Percentage of Participants
Interval 5.0 to 38.8
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16.0 Percentage of Participants
Interval 4.5 to 36.1
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6.3 Percentage of Participants
Interval 0.2 to 30.2
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12.0 Percentage of Participants
Interval 2.5 to 31.2
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11.5 Percentage of Participants
Interval 2.4 to 30.2
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13.0 Percentage of Participants
Interval 2.8 to 33.6
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16.7 Percentage of Participants
Interval 4.7 to 37.4
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5.6 Percentage of Participants
Interval 0.1 to 27.3
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34.8 Percentage of Participants
Interval 16.4 to 57.3
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20.0 Percentage of Participants
Interval 6.8 to 40.7
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13.6 Percentage of Participants
Interval 2.9 to 34.9
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11.5 Percentage of Participants
Interval 2.4 to 30.2
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25.9 Percentage of Participants
Interval 11.1 to 46.3
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8.0 Percentage of Participants
Interval 1.0 to 26.0
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4.2 Percentage of Participants
Interval 0.1 to 21.1
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13.0 Percentage of Participants
Interval 2.8 to 33.6
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SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 intervention. The number of participants with at least one AE was assessed.
Outcome measures
| Measure |
Cohort A1: Colon or Rectal Adenocarcinoma
n=475 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
|
Cohort A2: Anal Canal Squamous Cell Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
|
Cohort A3: Pancreas Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.
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Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
|
Cohort A5: Biliary Tract Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
|
Cohort A6: Carcinoid Tumors
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
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Cohort A7: Neuroendocrine Carcinomas
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
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Cohort B1: ER Positive HER2 Negative Breast Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.
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Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
|
Cohort B3: Endometrial Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.
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Cohort B4: Cervical Squamous Cell Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.
|
Cohort B5: Vulvar Squamous Cell Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
|
Cohort C1: Small Cell Lung Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.
|
Cohort C2: Mesothelioma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).
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Cohort D1: Thyroid Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).
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Cohort D2: Salivary Gland Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.
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Cohort D3: Nasopharyngeal Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.
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Cohort E1: Glioblastoma Multiforme
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.
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Cohort E2: Leiomyosarcoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.
|
Cohort E3: Prostate Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.
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Number of Participants Who Experienced an Adverse Event (AE)
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456 Participants
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SECONDARY outcome
Timeframe: Up to approximately 25 monthsPopulation: The analysis population consisted of all allocated participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 intervention. The number of participants who discontinued treatment due to an AE was assessed.
Outcome measures
| Measure |
Cohort A1: Colon or Rectal Adenocarcinoma
n=475 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
|
Cohort A2: Anal Canal Squamous Cell Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
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Cohort A3: Pancreas Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.
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Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
|
Cohort A5: Biliary Tract Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
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Cohort A6: Carcinoid Tumors
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
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Cohort A7: Neuroendocrine Carcinomas
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
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Cohort B1: ER Positive HER2 Negative Breast Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.
|
Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
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Cohort B3: Endometrial Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.
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Cohort B4: Cervical Squamous Cell Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.
|
Cohort B5: Vulvar Squamous Cell Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
|
Cohort C1: Small Cell Lung Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.
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Cohort C2: Mesothelioma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).
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Cohort D1: Thyroid Cancer
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).
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Cohort D2: Salivary Gland Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.
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Cohort D3: Nasopharyngeal Carcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.
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Cohort E1: Glioblastoma Multiforme
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.
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Cohort E2: Leiomyosarcoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.
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Cohort E3: Prostate Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.
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Number of Participants Who Discontinued From Study Treatment Due to an AE
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30 Participants
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SECONDARY outcome
Timeframe: Up to approximately 86 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.
PFS was defined as the time from the date of allocation to the date of the first documentation of disease progression, as determined by investigator per modified RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Cohort A1: Colon or Rectal Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
|
Cohort A2: Anal Canal Squamous Cell Carcinoma
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
|
Cohort A3: Pancreas Adenocarcinoma
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.
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Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
|
Cohort A5: Biliary Tract Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
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Cohort A6: Carcinoid Tumors
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
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Cohort A7: Neuroendocrine Carcinomas
n=16 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
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Cohort B1: ER Positive HER2 Negative Breast Cancer
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.
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Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
n=26 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
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Cohort B3: Endometrial Carcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.
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Cohort B4: Cervical Squamous Cell Cancer
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.
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Cohort B5: Vulvar Squamous Cell Carcinoma
n=18 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
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Cohort C1: Small Cell Lung Cancer
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.
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Cohort C2: Mesothelioma
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).
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Cohort D1: Thyroid Cancer
n=22 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).
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Cohort D2: Salivary Gland Carcinoma
n=26 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.
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Cohort D3: Nasopharyngeal Carcinoma
n=27 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.
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Cohort E1: Glioblastoma Multiforme
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.
|
Cohort E2: Leiomyosarcoma
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.
|
Cohort E3: Prostate Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
1.7 Months
Interval 1.4 to 1.8
|
3.1 Months
Interval 1.6 to 6.2
|
1.7 Months
Interval 1.5 to 1.8
|
1.8 Months
Interval 1.7 to 2.9
|
1.8 Months
Interval 1.4 to 2.1
|
5.5 Months
Interval 3.5 to 10.7
|
4.5 Months
Interval 3.5 to 13.9
|
1.8 Months
Interval 1.4 to 3.6
|
1.9 Months
Interval 1.8 to 3.5
|
1.8 Months
Interval 1.6 to 2.7
|
1.8 Months
Interval 1.6 to 3.2
|
2.5 Months
Interval 1.4 to 3.7
|
1.8 Months
Interval 1.7 to 5.8
|
5.5 Months
Interval 3.5 to 8.2
|
8.2 Months
Interval 2.2 to 14.4
|
3.6 Months
Interval 1.8 to 5.1
|
6.4 Months
Interval 3.5 to 13.4
|
2.8 Months
Interval 1.9 to 8.1
|
2.0 Months
Interval 1.7 to 5.3
|
3.5 Months
Interval 1.7 to 6.5
|
SECONDARY outcome
Timeframe: Up to approximately 86 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.
OS was defined as the time from the date of allocation to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the end of the trial were censored at the date of last assessment.
Outcome measures
| Measure |
Cohort A1: Colon or Rectal Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
|
Cohort A2: Anal Canal Squamous Cell Carcinoma
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
|
Cohort A3: Pancreas Adenocarcinoma
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.
|
Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
|
Cohort A5: Biliary Tract Adenocarcinoma
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
|
Cohort A6: Carcinoid Tumors
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
|
Cohort A7: Neuroendocrine Carcinomas
n=16 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
|
Cohort B1: ER Positive HER2 Negative Breast Cancer
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.
|
Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
n=26 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
|
Cohort B3: Endometrial Carcinoma
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.
|
Cohort B4: Cervical Squamous Cell Cancer
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.
|
Cohort B5: Vulvar Squamous Cell Carcinoma
n=18 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
|
Cohort C1: Small Cell Lung Cancer
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.
|
Cohort C2: Mesothelioma
n=25 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).
|
Cohort D1: Thyroid Cancer
n=22 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).
|
Cohort D2: Salivary Gland Carcinoma
n=26 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.
|
Cohort D3: Nasopharyngeal Carcinoma
n=27 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.
|
Cohort E1: Glioblastoma Multiforme
n=26 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.
|
Cohort E2: Leiomyosarcoma
n=24 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.
|
Cohort E3: Prostate Adenocarcinoma
n=23 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
5.3 Months
Interval 2.2 to 10.9
|
8.3 Months
Interval 5.8 to 16.2
|
3.9 Months
Interval 2.8 to 5.5
|
7.1 Months
Interval 4.3 to 17.7
|
5.7 Months
Interval 3.1 to 9.8
|
16.2 Months
Interval 7.6 to 22.4
|
37.8 Months
Interval 20.2 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
8.0 Months
Interval 6.5 to 10.3
|
13.1 Months
Interval 7.3 to 18.8
|
13.6 Months
Interval 2.2 to 25.2
|
10.8 Months
Interval 3.8 to 15.4
|
3.7 Months
Interval 3.1 to 7.7
|
9.3 Months
Interval 4.1 to 10.6
|
18.0 Months
Interval 10.3 to 24.4
|
39.7 Months
Interval 29.7 to 65.0
|
12.3 Months
Interval 6.0 to 30.1
|
16.5 Months
Interval 10.1 to 31.9
|
13.1 Months
Interval 8.0 to 26.6
|
12.0 Months
Interval 7.7 to 18.3
|
7.9 Months
Interval 6.5 to 15.3
|
SECONDARY outcome
Timeframe: Up to approximately 86 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1, had the intended indication, and experienced a response. Per protocol-specified definition, DOR could not be analyzed in arms which did not have a confirmed response of CR or PR.
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type.
Outcome measures
| Measure |
Cohort A1: Colon or Rectal Adenocarcinoma
n=1 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
|
Cohort A2: Anal Canal Squamous Cell Carcinoma
n=5 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
|
Cohort A3: Pancreas Adenocarcinoma
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.
|
Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
n=7 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
|
Cohort A5: Biliary Tract Adenocarcinoma
n=4 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
|
Cohort A6: Carcinoid Tumors
n=4 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
|
Cohort A7: Neuroendocrine Carcinomas
n=1 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
|
Cohort B1: ER Positive HER2 Negative Breast Cancer
n=3 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.
|
Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
n=3 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
|
Cohort B3: Endometrial Carcinoma
n=3 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.
|
Cohort B4: Cervical Squamous Cell Cancer
n=4 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.
|
Cohort B5: Vulvar Squamous Cell Carcinoma
n=1 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
|
Cohort C1: Small Cell Lung Cancer
n=8 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.
|
Cohort C2: Mesothelioma
n=5 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).
|
Cohort D1: Thyroid Cancer
n=3 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).
|
Cohort D2: Salivary Gland Carcinoma
n=3 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.
|
Cohort D3: Nasopharyngeal Carcinoma
n=7 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.
|
Cohort E1: Glioblastoma Multiforme
n=2 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.
|
Cohort E2: Leiomyosarcoma
n=1 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.
|
Cohort E3: Prostate Adenocarcinoma
n=3 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA Months
NA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
28.9 Months
Interval 3.8 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
—
|
14.5 Months
Interval 5.6 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
Interval 6.0 to
NA = Median, upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
10.1 Months
Interval 6.9 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
25.1 Months
Interval 25.1 to 25.1
|
12.0 Months
Interval 7.4 to 15.9
|
37.0 Months
Interval 34.4 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
68.5 Months
Interval 17.5 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
5.4 Months
Interval 4.1 to 7.5
|
3.9 Months
Interval 3.9 to 3.9
|
NA Months
NA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
12.0 Months
Interval 3.7 to 44.4
|
8.4 Months
Interval 4.6 to 20.3
|
3.9 Months
Interval 3.5 to 20.6
|
15.0 Months
Interval 4.8 to 34.0
|
15.6 Months
Interval 8.3 to 22.8
|
12.4 Months
Interval 12.4 to 12.4
|
14.2 Months
Interval 13.5 to 31.4
|
Adverse Events
First Course Pembrolizumab 10 mg/kg
Serious events: 160 serious events
Other events: 429 other events
Deaths: 426 deaths
Second Course Pembrolizumab 10 mg/kg
Serious events: 3 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
First Course Pembrolizumab 10 mg/kg
n=475 participants at risk
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years.
|
Second Course Pembrolizumab 10 mg/kg
n=11 participants at risk
Qualified participants who completed the first course of pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 10 mg/kg IV Q2W for up to \~1 year.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
5/475 • Number of events 5 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Cardiac disorders
Atrial fibrillation
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Cardiac disorders
Atrial tachycardia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Cardiac disorders
Pericardial effusion
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Endocrine disorders
Hypothyroidism
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.84%
4/475 • Number of events 4 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Ascites
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Colitis
|
1.5%
7/475 • Number of events 8 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Constipation
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
5/475 • Number of events 5 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Enteritis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Gastritis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Ileus
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Melaena
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Subileus
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Chest pain
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Complication associated with device
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Death
|
0.84%
4/475 • Number of events 4 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
General physical health deterioration
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Influenza like illness
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Malaise
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Non-cardiac chest pain
|
0.21%
1/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Oedema
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Pyrexia
|
1.7%
8/475 • Number of events 11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Biliary colic
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Cholangitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Cholestasis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Hepatitis
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Jaundice
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Hepatobiliary disorders
Liver disorder
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Immune system disorders
Cytokine release syndrome
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Abdominal sepsis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Bacteraemia
|
0.63%
3/475 • Number of events 4 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Biliary sepsis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Cellulitis
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Device related bacteraemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Device related infection
|
0.21%
1/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Device related sepsis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Escherichia sepsis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Gastroenteritis viral
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Helicobacter infection
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Infection
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Infectious mononucleosis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Infectious pleural effusion
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Liver abscess
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Meningitis bacterial
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Osteomyelitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Otitis media
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Pelvic abscess
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Peritonitis
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Pneumonia
|
1.3%
6/475 • Number of events 6 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Pulmonary sepsis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Salmonellosis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Sepsis
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Septic shock
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Streptococcal sepsis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Subcutaneous abscess
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Urinary tract infection
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Wound infection
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Alanine aminotransferase increased
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Aspartate aminotransferase increased
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Transaminases increased
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
5/475 • Number of events 5 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.1%
5/475 • Number of events 5 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Altered state of consciousness
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Epilepsy
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Hydrocephalus
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Ischaemic stroke
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Migraine
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Myelitis transverse
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Presyncope
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Seizure
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Syncope
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Product Issues
Device occlusion
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Psychiatric disorders
Anxiety
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Psychiatric disorders
Confusional state
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Psychiatric disorders
Depression
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Psychiatric disorders
Mental status changes
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Renal and urinary disorders
Haematuria
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Renal and urinary disorders
Renal failure
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Renal and urinary disorders
Urinary retention
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.21%
1/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Noninfective bronchitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
8/475 • Number of events 9 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
5/475 • Number of events 5 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Haemorrhage
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Hypotension
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Lymphoedema
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Lymphorrhoea
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Thrombosis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
Other adverse events
| Measure |
First Course Pembrolizumab 10 mg/kg
n=475 participants at risk
Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years.
|
Second Course Pembrolizumab 10 mg/kg
n=11 participants at risk
Qualified participants who completed the first course of pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 10 mg/kg IV Q2W for up to \~1 year.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.3%
87/475 • Number of events 101 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Endocrine disorders
Hypothyroidism
|
8.0%
38/475 • Number of events 39 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
54/475 • Number of events 59 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
28/475 • Number of events 31 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Constipation
|
19.6%
93/475 • Number of events 105 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.5%
102/475 • Number of events 177 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
27.3%
3/11 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
29/475 • Number of events 30 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Nausea
|
26.1%
124/475 • Number of events 149 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
75/475 • Number of events 99 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Asthenia
|
12.4%
59/475 • Number of events 68 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Fatigue
|
34.7%
165/475 • Number of events 176 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Oedema peripheral
|
9.1%
43/475 • Number of events 47 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Pyrexia
|
15.6%
74/475 • Number of events 97 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
31/475 • Number of events 39 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Aspartate aminotransferase increased
|
7.8%
37/475 • Number of events 45 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.4%
40/475 • Number of events 41 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Weight decreased
|
7.4%
35/475 • Number of events 36 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.5%
102/475 • Number of events 106 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.4%
35/475 • Number of events 37 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
31/475 • Number of events 33 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.8%
37/475 • Number of events 46 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.2%
34/475 • Number of events 36 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.2%
77/475 • Number of events 101 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
18.2%
2/11 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
56/475 • Number of events 64 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
27.3%
3/11 • Number of events 4 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
38/475 • Number of events 49 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
30/475 • Number of events 34 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Dizziness
|
8.8%
42/475 • Number of events 54 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Headache
|
13.3%
63/475 • Number of events 73 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Psychiatric disorders
Depression
|
5.3%
25/475 • Number of events 26 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Psychiatric disorders
Insomnia
|
9.3%
44/475 • Number of events 45 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.5%
69/475 • Number of events 89 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.6%
60/475 • Number of events 67 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
24/475 • Number of events 25 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
18.2%
2/11 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.5%
69/475 • Number of events 88 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
18.2%
2/11 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
56/475 • Number of events 71 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
25/475 • Number of events 28 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
0.00%
0/11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Oral pain
|
1.7%
8/475 • Number of events 9 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.84%
4/475 • Number of events 7 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Investigations
Hepatic enzyme increased
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.7%
13/475 • Number of events 13 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
5/475 • Number of events 6 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
18/475 • Number of events 18 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Nervous system disorders
Memory impairment
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Renal and urinary disorders
Hematuria
|
2.1%
10/475 • Number of events 19 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.4%
16/475 • Number of events 17 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
8/475 • Number of events 8 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.63%
3/475 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.42%
2/475 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
27.3%
3/11 • Number of events 5 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Hypotension
|
4.2%
20/475 • Number of events 21 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.84%
4/475 • Number of events 4 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Conjunctivitis
|
1.5%
7/475 • Number of events 7 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
18.2%
2/11 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Gingivitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Oral candidiasis
|
1.5%
7/475 • Number of events 7 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
21/475 • Number of events 27 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.5%
7/475 • Number of events 7 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
14/475 • Number of events 19 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
18.2%
2/11 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Chest pain
|
4.2%
20/475 • Number of events 23 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
General disorders
Influenza like illness
|
2.3%
11/475 • Number of events 16 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
18.2%
2/11 • Number of events 3 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/475 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Eye disorders
Cataract
|
1.1%
5/475 • Number of events 5 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Eye disorders
Dry eye
|
2.3%
11/475 • Number of events 11 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
18.2%
2/11 • Number of events 2 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
|
Eye disorders
Uveitis
|
0.21%
1/475 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
9.1%
1/11 • Number of events 1 • Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.
ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.
|
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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER