Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study (NCT NCT03933449)
NCT ID: NCT03933449
Last Updated: 2023-03-29
Results Overview
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in all participants is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
123 participants
Primary outcome timeframe
From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)
Results posted on
2023-03-29
Participant Flow
Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures. Final analysis of all outcome measures was done at the protocol-specified analysis cutoff of 13-Feb-2019.
Participant milestones
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years). Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) but progressed after discontinuation, were eligible for a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
|
Chemotherapy
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
|
Overall Study
Treated
|
62
|
59
|
|
Overall Study
Received Second Course
|
1
|
0
|
|
Overall Study
Discontinued
|
62
|
61
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
62
|
61
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years). Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) but progressed after discontinuation, were eligible for a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
|
Chemotherapy
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Death
|
55
|
57
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=62 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years). Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) but progressed after discontinuation, were eligible for a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
|
Chemotherapy
n=61 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
59.6 Years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
59.9 Years
STANDARD_DEVIATION 7.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS)
PD-L1 CPS ≥10
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS)
PD-L1 CPS <10
|
35 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS)
Not Evaluable
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Tumor Histology
Squamous cell carcinoma
|
60 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Tumor Histology
Adenocarcinoma of esophagus & EGJ Siewert type I
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in all participants is presented.
Outcome measures
| Measure |
Pembrolizumab
n=62 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=61 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Overall Survival (OS) in All Participants
|
8.4 Months
Interval 5.8 to 10.9
|
5.6 Months
Interval 4.5 to 7.3
|
PRIMARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with a PD-L1 CPS ≥10 is presented.
Outcome measures
| Measure |
Pembrolizumab
n=25 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=29 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
|
12.0 Months
Interval 6.6 to
NA=OS Upper Limit could not be calculated due to an insufficient number of deaths on study as of the data cutoff date of 13-Feb-2019
|
5.3 Months
Interval 4.1 to 8.2
|
PRIMARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
OS was defined as the time from randomization to death due to any cause. Median OS for the first pembrolizumab course in participants with SCC of the esophagus is presented.
Outcome measures
| Measure |
Pembrolizumab
n=60 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=59 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
|
8.4 Months
Interval 5.8 to 10.9
|
5.6 Months
Interval 4.5 to 7.3
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of all participants who experienced a CR or PR for the first pembrolizumab course is presented.
Outcome measures
| Measure |
Pembrolizumab
n=62 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=61 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
|
16.1 Percentage of Participants
Interval 8.0 to 27.7
|
3.3 Percentage of Participants
Interval 0.4 to 11.3
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10 who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR for the first pembrolizumab course is presented.
Outcome measures
| Measure |
Pembrolizumab
n=25 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=29 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
|
24.0 Percentage of Participants
Interval 9.4 to 45.1
|
6.9 Percentage of Participants
Interval 0.8 to 22.8
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with SCC of the esophagus who experienced a CR or PR for the first pembrolizumab course is presented.
Outcome measures
| Measure |
Pembrolizumab
n=60 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=59 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
|
16.7 Percentage of Participants
Interval 8.3 to 28.5
|
3.4 Percentage of Participants
Interval 0.4 to 11.7
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 in all participants is presented.
Outcome measures
| Measure |
Pembrolizumab
n=62 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=61 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
|
2.5 Months
Interval 2.1 to 4.1
|
2.8 Months
Interval 2.0 to 4.2
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.
Outcome measures
| Measure |
Pembrolizumab
n=25 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=29 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
|
4.0 Months
Interval 2.1 to 6.1
|
4.0 Months
Interval 2.0 to 5.3
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS for the first pembrolizumab course as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with SCC of the esophagus.
Outcome measures
| Measure |
Pembrolizumab
n=60 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=59 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
|
2.3 Months
Interval 2.1 to 4.1
|
2.8 Months
Interval 2.0 to 4.2
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: All randomized participants who received at least one dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE for the first pembrolizumab course are presented.
Outcome measures
| Measure |
Pembrolizumab
n=62 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=59 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
62 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months)Population: All randomized participants who received at least one dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE for the first pembrolizumab course are presented.
Outcome measures
| Measure |
Pembrolizumab
n=62 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3 week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=59 Participants
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)
|
10 Participants
|
9 Participants
|
Adverse Events
Pembrolizumab First Course
Serious events: 23 serious events
Other events: 58 other events
Deaths: 61 deaths
Chemotherapy
Serious events: 23 serious events
Other events: 55 other events
Deaths: 61 deaths
Pembrolizumab Second Course
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab First Course
n=62 participants at risk
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=59 participants at risk
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
Pembrolizumab Second Course
n=1 participants at risk
Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Chest discomfort
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Death
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Pyrexia
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Hepatobiliary disorders
Liver injury
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Infections and infestations
Oesophageal infection
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Infections and infestations
Pneumonia
|
4.8%
3/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Platelet count decreased
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/59 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
Other adverse events
| Measure |
Pembrolizumab First Course
n=62 participants at risk
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to \~2 years).
|
Chemotherapy
n=59 participants at risk
Participants received Investigator's choice of chemotherapy for up to \~2 years: paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle.
|
Pembrolizumab Second Course
n=1 participants at risk
Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.6%
19/62 • Number of events 24 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
50.8%
30/59 • Number of events 49 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
100.0%
1/1 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
11.9%
7/59 • Number of events 23 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
8.5%
5/59 • Number of events 17 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Endocrine disorders
Hypothyroidism
|
19.4%
12/62 • Number of events 15 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
4/62 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
3/62 • Number of events 5 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.1%
5/62 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
6.8%
4/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Constipation
|
16.1%
10/62 • Number of events 13 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
16.9%
10/59 • Number of events 14 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.9%
8/62 • Number of events 9 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
28.8%
17/59 • Number of events 39 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Dysphagia
|
8.1%
5/62 • Number of events 5 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.7%
6/62 • Number of events 8 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
10.2%
6/59 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Nausea
|
9.7%
6/62 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
27.1%
16/59 • Number of events 22 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
100.0%
1/1 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
5/62 • Number of events 8 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
32.2%
19/59 • Number of events 37 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Asthenia
|
19.4%
12/62 • Number of events 12 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
6.8%
4/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Chest pain
|
8.1%
5/62 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Fatigue
|
4.8%
3/62 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
16.9%
10/59 • Number of events 10 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Malaise
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
10.2%
6/59 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
General disorders
Pyrexia
|
8.1%
5/62 • Number of events 8 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
15.3%
9/59 • Number of events 13 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
100.0%
1/1 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.5%
4/62 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Infections and infestations
Pneumonia
|
14.5%
9/62 • Number of events 11 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
13.6%
8/59 • Number of events 8 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
4/62 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Alanine aminotransferase increased
|
17.7%
11/62 • Number of events 12 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
6.8%
4/59 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Aspartate aminotransferase increased
|
9.7%
6/62 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
8.5%
5/59 • Number of events 8 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.5%
4/62 • Number of events 5 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Blood bilirubin increased
|
6.5%
4/62 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Blood glucose increased
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.8%
3/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
6.8%
4/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Blood urea increased
|
3.2%
2/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.9%
8/62 • Number of events 8 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
6.8%
4/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Lymphocyte count decreased
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
13.6%
8/59 • Number of events 10 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Neutrophil count decreased
|
3.2%
2/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
28.8%
17/59 • Number of events 55 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Neutrophil count increased
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Platelet count decreased
|
6.5%
4/62 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
8.5%
5/59 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Tri-iodothyronine decreased
|
1.6%
1/62 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
Weight decreased
|
21.0%
13/62 • Number of events 13 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
27.1%
16/59 • Number of events 18 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
White blood cell count decreased
|
6.5%
4/62 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
47.5%
28/59 • Number of events 80 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Investigations
White blood cell count increased
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.7%
11/62 • Number of events 12 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
18.6%
11/59 • Number of events 13 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
100.0%
1/1 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.5%
4/62 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.7%
6/62 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
24.2%
15/62 • Number of events 24 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
18.6%
11/59 • Number of events 13 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
6.5%
4/62 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.1%
5/62 • Number of events 5 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
18.6%
11/59 • Number of events 14 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
3/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
8.5%
5/59 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
4.8%
3/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
6.8%
4/59 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
4/62 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
3.4%
2/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.3%
7/62 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
8.1%
5/62 • Number of events 5 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Nervous system disorders
Headache
|
4.8%
3/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
100.0%
1/1 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Psychiatric disorders
Insomnia
|
4.8%
3/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
6.8%
4/59 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Renal and urinary disorders
Haematuria
|
3.2%
2/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Renal and urinary disorders
Proteinuria
|
9.7%
6/62 • Number of events 6 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.0%
13/62 • Number of events 20 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
11.9%
7/59 • Number of events 9 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.2%
2/62 • Number of events 2 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
6/62 • Number of events 8 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.5%
4/62 • Number of events 4 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
5.1%
3/59 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.8%
3/62 • Number of events 3 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
11.9%
7/59 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/62 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
11.9%
7/59 • Number of events 7 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
4/62 • Number of events 5 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
1.7%
1/59 • Number of events 1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs separately.
|
0.00%
0/1 • From randomization through end-of-trial analysis data cutoff date of 14-March-2022 (Up to ~52 months)
All-Cause Mortality (ACM): All randomized participants. Safety: All randomized participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for ACM and AEs 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 study 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