Trial Outcomes & Findings for Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006) (NCT NCT03976323)
NCT ID: NCT03976323
Last Updated: 2026-02-25
Results Overview
PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. 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 one or more new lesions was also considered PD. PFS was analyzed by the non-parametric Kaplan-Meier (K-M) method. The protocol specified final analysis of PFS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1003 participants
Primary outcome timeframe
Up to ~31 months
Results posted on
2026-02-25
Participant Flow
Per protocol, response or progression during the second pembrolizumab course were not counted towards patient reported outcomes (PROs) or efficacy outcome measures and adverse events during the second pembrolizumab course will not be counted towards safety outcome measures.
Participant milestones
| Measure |
Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)
Participants received 4 cycles (up to \~12 weeks \[cycle = 3 weeks\]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m\^2 IV on Day 1 of each cycle (Cycles 1 through 4).
|
Pembrolizumab + Olaparib (Maintenance Phase)
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|---|
|
Induction Phase
STARTED
|
1003
|
0
|
0
|
|
Induction Phase
COMPLETED
|
672
|
0
|
0
|
|
Induction Phase
NOT COMPLETED
|
331
|
0
|
0
|
|
Maintenance Phase
STARTED
|
0
|
337
|
335
|
|
Maintenance Phase
Treated
|
0
|
337
|
332
|
|
Maintenance Phase
Received Second Course of Pembrolizumab
|
0
|
7
|
13
|
|
Maintenance Phase
COMPLETED
|
0
|
0
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
0
|
337
|
335
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)
Participants received 4 cycles (up to \~12 weeks \[cycle = 3 weeks\]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m\^2 IV on Day 1 of each cycle (Cycles 1 through 4).
|
Pembrolizumab + Olaparib (Maintenance Phase)
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|---|
|
Induction Phase
Failure to Meet Maintenance Randomization Criteria
|
251
|
0
|
0
|
|
Induction Phase
Death
|
80
|
0
|
0
|
|
Maintenance Phase
Participant Ongoing in Study
|
0
|
100
|
97
|
|
Maintenance Phase
Withdrawal by Subject
|
0
|
9
|
3
|
|
Maintenance Phase
Physician Decision
|
0
|
0
|
1
|
|
Maintenance Phase
Death
|
0
|
228
|
234
|
Baseline Characteristics
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)
n=331 Participants
Participants received 4 cycles (up to \~12 weeks \[cycle = 3 weeks\]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m\^2 IV on Day 1 of each cycle (Cycles 1 through 4).
|
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=335 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Total
n=1003 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 9.4 • n=331 Participants
|
61.6 Years
STANDARD_DEVIATION 8.6 • n=337 Participants
|
61.8 Years
STANDARD_DEVIATION 9.8 • n=335 Participants
|
62.3 Years
STANDARD_DEVIATION 9.3 • n=1003 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=331 Participants
|
110 Participants
n=337 Participants
|
109 Participants
n=335 Participants
|
328 Participants
n=1003 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=331 Participants
|
227 Participants
n=337 Participants
|
226 Participants
n=335 Participants
|
675 Participants
n=1003 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=331 Participants
|
50 Participants
n=337 Participants
|
67 Participants
n=335 Participants
|
176 Participants
n=1003 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
246 Participants
n=331 Participants
|
263 Participants
n=337 Participants
|
253 Participants
n=335 Participants
|
762 Participants
n=1003 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=331 Participants
|
24 Participants
n=337 Participants
|
15 Participants
n=335 Participants
|
65 Participants
n=1003 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=331 Participants
|
4 Participants
n=337 Participants
|
1 Participants
n=335 Participants
|
10 Participants
n=1003 Participants
|
|
Race (NIH/OMB)
Asian
|
56 Participants
n=331 Participants
|
91 Participants
n=337 Participants
|
72 Participants
n=335 Participants
|
219 Participants
n=1003 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=331 Participants
|
2 Participants
n=337 Participants
|
2 Participants
n=335 Participants
|
4 Participants
n=1003 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=331 Participants
|
4 Participants
n=337 Participants
|
8 Participants
n=335 Participants
|
21 Participants
n=1003 Participants
|
|
Race (NIH/OMB)
White
|
236 Participants
n=331 Participants
|
218 Participants
n=337 Participants
|
234 Participants
n=335 Participants
|
688 Participants
n=1003 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=331 Participants
|
7 Participants
n=337 Participants
|
9 Participants
n=335 Participants
|
27 Participants
n=1003 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=331 Participants
|
11 Participants
n=337 Participants
|
9 Participants
n=335 Participants
|
34 Participants
n=1003 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline of Maintenance Phase
Grade 0
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
142 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
135 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
277 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline of Maintenance Phase
Grade 1
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
195 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
200 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
395 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
|
Response at Baseline of Maintenance Phase
Complete Response (CR)/Partial Response (PR)
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
189 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
192 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
381 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
|
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline of Maintenance Phase
TPS<50%
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
228 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
223 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
451 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
|
Response at Baseline of Maintenance Phase
Stable Disease (SD)
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
148 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
143 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
291 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
|
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline of Maintenance Phase
TPS ≥50%
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
109 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
110 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
219 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
|
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline of Maintenance Phase
Not Evaluable
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
0 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
1 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
1 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
|
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline of Maintenance Phase
Missing
|
0 Participants
All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
0 Participants
n=337 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
1 Participants
n=335 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
1 Participants
n=672 Participants • All participants randomized to the maintenance phase. Per protocol, data for this study specific baseline measure were not planned to be collected or reported for the induction phase.
|
PRIMARY outcome
Timeframe: Up to ~31 monthsPopulation: All randomized participants in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. 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 one or more new lesions was also considered PD. PFS was analyzed by the non-parametric Kaplan-Meier (K-M) method. The protocol specified final analysis of PFS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=335 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.1 Months
Interval 5.6 to 8.7
|
8.3 Months
Interval 6.9 to 11.5
|
PRIMARY outcome
Timeframe: Up to ~51 monthsPopulation: All randomized participants in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
OS was defined as the time from randomization to death due to any cause. OS was analyzed by the non-parametric K-M method. Participants without documented death at the time of analyses were censored at the date of last known to be alive. The protocol specified final analysis of OS is presented here for the first pembrolizumab course in the Maintenance Phase. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=335 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Overall Survival (OS)
|
20.7 Months
Interval 18.0 to 24.8
|
23.0 Months
Interval 19.0 to 26.4
|
SECONDARY outcome
Timeframe: Up to ~5 yearsAn AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to ~5 yearsAn AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. The protocol specified final analysis will be presented for the first pembrolizumab course.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 patient reported outcome (PRO) assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in GHS and QoL combined score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=332 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score
|
-5.34 Scores on a scale
Interval -7.78 to -2.9
|
-3.44 Scores on a scale
Interval -5.9 to -0.98
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-C30 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.
EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome was not done in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=329 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=316 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
|
19.81 Months
Interval 15.97 to
Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
17.28 Months
Interval 9.46 to
Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 PRO assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=332 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
|
-1.98 Scores on a scale
Interval -4.9 to 0.94
|
-1.82 Scores on a scale
Interval -4.77 to 1.12
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-LC13 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding cough (Item 1): "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 1). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=325 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=315 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
TTD in EORTC QLQ-LC13 Cough (Item 1) Scale Score
|
NA Months
Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 PRO assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=332 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
|
-0.82 Scores on a scale
Interval -3.25 to 1.61
|
-0.47 Scores on a scale
Interval -2.92 to 1.98
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had EORTC QLQ-LC13 data available for this outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.
EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question regarding chest pain (Item 10): "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in chest pain (Item 10). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=325 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=315 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
TTD in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
|
NA Months
Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 PRO assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=332 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
|
-0.16 Scores on a scale
Interval -3.07 to 2.76
|
1.35 Scores on a scale
Interval -1.6 to 4.31
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-C30 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question regarding dyspnea (Item 8): "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=329 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=316 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
TTD in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
|
NA Months
Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Median, upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment and had at least 1 PRO assessment available. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score is presented. The protocol specified final analysis for the first pembrolizumab course in Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=337 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=332 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
|
-2.79 Scores on a scale
Interval -4.92 to -0.65
|
-2.78 Scores on a scale
Interval -4.93 to -0.62
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: All randomized participants in the Maintenance Phase who received at least one dose of Maintenance Phase study treatment, had at least 1 PRO assessment and had data available for this EORTC QLQ-C30 outcome measure. Per protocol, analysis for this outcome was not planned or conducted in the Induction Phase.
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). TTD estimated by non-parametric K-M method is presented here. A longer TTD indicates a better outcome. The protocol specified final analysis for the first pembrolizumab course in the Maintenance Phase is reported. Per protocol, analysis for this outcome measure was not planned or conducted in the Induction Phase.
Outcome measures
| Measure |
Pembrolizumab + Olaparib (Maintenance Phase)
n=329 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab + Pemetrexed (Maintenance Phase)
n=316 Participants
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]). Qualified participants who completed up to \~35 cycles of pembrolizumab (up to \~2 years) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|
|
TTD in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
|
20.96 Months
Interval 13.34 to
Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 17.28 to
Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
Adverse Events
Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)
Serious events: 235 serious events
Other events: 872 other events
Deaths: 116 deaths
Pembrolizumab (First Course) + Olaparib (Maintenance Phase)
Serious events: 118 serious events
Other events: 298 other events
Deaths: 233 deaths
Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase)
Serious events: 125 serious events
Other events: 289 other events
Deaths: 233 deaths
Pembrolizumab (Second Course) + Olaparib (Maintenance Phase)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)
n=1003 participants at risk
Participants received 4 cycles (up to \~12 weeks \[cycle = 3 weeks\]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m\^2 IV on Day 1 of each cycle (Cycles 1 through 4).
|
Pembrolizumab (First Course) + Olaparib (Maintenance Phase)
n=337 participants at risk
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]).
|
Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase)
n=332 participants at risk
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]).
|
Pembrolizumab (Second Course) + Olaparib (Maintenance Phase)
n=7 participants at risk
In the Maintenance Phase, qualified participants who received pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) plus olaparib (300 mg orally twice daily until progressive disease or toxicity) and who completed up to \~35 cycles of pembrolizumab (up to \~2 years \[cycle =3 weeks\]) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase)
n=13 participants at risk
In the Maintenance Phase, qualified participants who received pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) plus pemetrexed (500 mg/m\^2 IV on Day 1 of each 3-week cycle until progressive disease or toxicity) and who completed up to \~35 cycles of pembrolizumab (up to \~2 years \[cycle =3 weeks\]) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
24/1003 • Number of events 25 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
2.7%
9/337 • Number of events 9 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
2.4%
8/332 • Number of events 8 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
11/1003 • Number of events 11 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.70%
7/1003 • Number of events 8 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
11/1003 • Number of events 14 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
18/1003 • Number of events 22 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Acute coronary syndrome
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Atrial fibrillation
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Atrial tachycardia
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Bradycardia
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.2%
4/337 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Cardiac tamponade
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Myocarditis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Pericardial effusion
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Pericarditis
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Ear and labyrinth disorders
Vertigo
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Endocrine disorders
Adrenal insufficiency
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Endocrine disorders
Hypothyroidism
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Eye disorders
Cataract
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Ascites
|
0.20%
2/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
4/1003 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Nausea
|
0.60%
6/1003 • Number of events 6 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Asthenia
|
0.40%
4/1003 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Chest pain
|
0.40%
4/1003 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Death
|
0.80%
8/1003 • Number of events 8 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.89%
3/337 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.5%
5/332 • Number of events 5 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Fatigue
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Gait disturbance
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
General physical health deterioration
|
0.80%
8/1003 • Number of events 8 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Hyperthermia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Malaise
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Oedema peripheral
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Pyrexia
|
0.90%
9/1003 • Number of events 9 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Serositis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Sudden death
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Bile duct stone
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Cholangitis
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Hepatic failure
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Hepatitis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.89%
3/337 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Immune-mediated cholangitis
|
0.10%
1/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
COVID-19
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.8%
6/337 • Number of events 6 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
COVID-19 pneumonia
|
0.90%
9/1003 • Number of events 9 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.8%
6/337 • Number of events 6 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.1%
17/332 • Number of events 18 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Cellulitis
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Device related infection
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Empyema
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Encephalitis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.2%
4/332 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Gangrene
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Giardiasis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Infectious pleural effusion
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Influenza
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Laryngitis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Lower respiratory tract infection
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Pleural infection
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Pneumonia
|
2.3%
23/1003 • Number of events 23 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
4.2%
14/337 • Number of events 16 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.3%
11/332 • Number of events 11 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Pneumonia aspiration
|
0.20%
2/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Pneumonia bacterial
|
0.10%
1/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.90%
3/332 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
1/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Prostate infection
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Pulmonary sepsis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Rectal abscess
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Respiratory tract infection
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Sepsis
|
1.1%
11/1003 • Number of events 11 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Septic shock
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Serratia infection
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Suspected COVID-19
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Testicular abscess
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Urethritis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Urinary tract infection
|
0.50%
5/1003 • Number of events 6 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Viral infection
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Wound infection
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Head injury
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Blood creatinine increased
|
0.10%
1/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Transaminases increased
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Weight decreased
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.40%
4/1003 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Aortitis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Brain oedema
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Brain injury
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Cerebral ischaemia
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Cognitive disorder
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Dural arteriovenous fistula
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Encephalopathy
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Epilepsy
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Headache
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Paraesthesia
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Seizure
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Speech disorder
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Syncope
|
0.30%
3/1003 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.90%
3/332 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Product Issues
Device dislocation
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Psychiatric disorders
Confusional state
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Psychiatric disorders
Suicide attempt
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Acute kidney injury
|
0.60%
6/1003 • Number of events 6 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.90%
3/332 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Dysuria
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Nephritis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Nephropathy
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Renal failure
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.89%
3/337 • Number of events 5 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.5%
5/332 • Number of events 6 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.70%
7/1003 • Number of events 7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.89%
3/337 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
11/1003 • Number of events 12 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.5%
5/332 • Number of events 5 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.70%
7/1003 • Number of events 7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
2.1%
7/337 • Number of events 7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.0%
10/332 • Number of events 10 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.00%
10/1003 • Number of events 10 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
2.1%
7/337 • Number of events 7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Angiodysplasia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Arterial thrombosis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Embolism
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Haemorrhage
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Hypertension
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Hypotension
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Subclavian artery embolism
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Superficial vein thrombosis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Superior vena cava syndrome
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Thrombosis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Vascular occlusion
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
Other adverse events
| Measure |
Pembrolizumab + Pemetrexed + Platinum Therapy (Induction Phase)
n=1003 participants at risk
Participants received 4 cycles (up to \~12 weeks \[cycle = 3 weeks\]): pembrolizumab 200 mg intravenous (IV) on Day 1 of each cycle (cycles 1 through 4) PLUS pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle (cycles 1 through 4) PLUS platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of each cycle (Cycles 1 through 4) OR cisplatin 75 mg/m\^2 IV on Day 1 of each cycle (Cycles 1 through 4).
|
Pembrolizumab (First Course) + Olaparib (Maintenance Phase)
n=337 participants at risk
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, participants continued to receive maintenance olaparib until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]).
|
Pembrolizumab (First Course) + Pemetrexed (Maintenance Phase)
n=332 participants at risk
Eligible participants with a complete/partial response or stable disease to treatment in the Induction Phase could enter the Maintenance Phase. For the Maintenance Phase, participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 31 cycles PLUS maintenance pemetrexed 500 mg/m\^2 IV on Day 1 of each 3-week cycle. In the Maintenance Phase, participants continued to receive maintenance pemetrexed until progressive disease or toxicity. Across both phases, participants could receive pembrolizumab for a total treatment duration of up to \~35 cycles (up to \~2 years \[cycle = 3 weeks\]).
|
Pembrolizumab (Second Course) + Olaparib (Maintenance Phase)
n=7 participants at risk
In the Maintenance Phase, qualified participants who received pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) plus olaparib (300 mg orally twice daily until progressive disease or toxicity) and who completed up to \~35 cycles of pembrolizumab (up to \~2 years \[cycle =3 weeks\]) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
Pembrolizumab (Second Course) + Pemetrexed (Maintenance Phase)
n=13 participants at risk
In the Maintenance Phase, qualified participants who received pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) plus pemetrexed (500 mg/m\^2 IV on Day 1 of each 3-week cycle until progressive disease or toxicity) and who completed up to \~35 cycles of pembrolizumab (up to \~2 years \[cycle =3 weeks\]) may have been eligible to receive a second course of pembrolizumab at the same dose and schedule (200 mg on Day 1 of each 3-week cycle) for up to \~17 cycles (up to \~1 additional year).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
38.4%
385/1003 • Number of events 432 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
36.2%
122/337 • Number of events 176 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
37.7%
125/332 • Number of events 199 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
14.3%
1/7 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
15.4%
2/13 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.1%
141/1003 • Number of events 208 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
14.2%
48/337 • Number of events 83 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.7%
19/332 • Number of events 41 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.7%
17/1003 • Number of events 22 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.6%
19/337 • Number of events 31 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
4.2%
14/332 • Number of events 24 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.4%
235/1003 • Number of events 371 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
16.9%
57/337 • Number of events 105 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.6%
32/332 • Number of events 60 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.4%
114/1003 • Number of events 156 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
16.9%
57/337 • Number of events 93 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
10.5%
35/332 • Number of events 60 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Endocrine disorders
Hypothyroidism
|
2.7%
27/1003 • Number of events 27 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
10.4%
35/337 • Number of events 41 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.7%
19/332 • Number of events 20 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
14.3%
1/7 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.8%
6/332 • Number of events 7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Constipation
|
16.8%
169/1003 • Number of events 199 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
6.2%
21/337 • Number of events 24 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
11.7%
39/332 • Number of events 52 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Diarrhoea
|
10.1%
101/1003 • Number of events 121 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
11.6%
39/337 • Number of events 63 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
10.5%
35/332 • Number of events 57 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Nausea
|
30.9%
310/1003 • Number of events 485 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
24.0%
81/337 • Number of events 106 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
19.0%
63/332 • Number of events 167 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
83/1003 • Number of events 110 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.3%
28/337 • Number of events 42 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.2%
24/332 • Number of events 35 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Asthenia
|
10.7%
107/1003 • Number of events 141 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.2%
31/337 • Number of events 42 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
11.4%
38/332 • Number of events 60 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Chest pain
|
2.8%
28/1003 • Number of events 28 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
6.5%
22/337 • Number of events 22 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
6.0%
20/332 • Number of events 24 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Early satiety
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Fatigue
|
14.0%
140/1003 • Number of events 161 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
17.2%
58/337 • Number of events 72 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
16.3%
54/332 • Number of events 73 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Influenza like illness
|
0.40%
4/1003 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.5%
5/332 • Number of events 5 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Oedema peripheral
|
2.3%
23/1003 • Number of events 23 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.3%
11/337 • Number of events 11 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
14.8%
49/332 • Number of events 66 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
General disorders
Pyrexia
|
5.4%
54/1003 • Number of events 62 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
10.7%
36/337 • Number of events 43 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.1%
27/332 • Number of events 48 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Hepatobiliary disorders
Hepatitis
|
0.40%
4/1003 • Number of events 5 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/337 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.2%
4/332 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
COVID-19
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.6%
29/337 • Number of events 34 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.4%
28/332 • Number of events 28 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
14.3%
1/7 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Infections and infestations
Rhinitis
|
0.20%
2/1003 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.59%
2/337 • Number of events 5 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Alanine aminotransferase increased
|
11.0%
110/1003 • Number of events 122 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.2%
31/337 • Number of events 42 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
15.7%
52/332 • Number of events 97 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Aspartate aminotransferase increased
|
8.1%
81/1003 • Number of events 91 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.3%
28/337 • Number of events 38 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
16.6%
55/332 • Number of events 86 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Blood alkaline phosphatase increased
|
3.3%
33/1003 • Number of events 35 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.0%
10/337 • Number of events 12 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
4.2%
14/332 • Number of events 19 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Blood creatinine increased
|
3.5%
35/1003 • Number of events 37 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
13.6%
46/337 • Number of events 63 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
12.0%
40/332 • Number of events 67 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.7%
17/1003 • Number of events 17 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.2%
4/337 • Number of events 6 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.0%
10/332 • Number of events 14 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Investigations
Weight decreased
|
2.9%
29/1003 • Number of events 30 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.2%
31/337 • Number of events 39 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.4%
18/332 • Number of events 20 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.5%
155/1003 • Number of events 190 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
15.4%
52/337 • Number of events 77 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
15.7%
52/332 • Number of events 79 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 3 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.2%
32/1003 • Number of events 32 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.6%
12/337 • Number of events 17 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.5%
25/332 • Number of events 33 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
24/1003 • Number of events 28 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
4.5%
15/337 • Number of events 29 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
4.2%
14/332 • Number of events 30 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.2%
12/1003 • Number of events 13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
2.7%
9/337 • Number of events 9 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.6%
12/332 • Number of events 15 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
30/1003 • Number of events 33 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.3%
11/337 • Number of events 16 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.7%
19/332 • Number of events 24 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
21/1003 • Number of events 24 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
2.7%
9/337 • Number of events 14 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.0%
10/332 • Number of events 12 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
14.3%
1/7 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
34/1003 • Number of events 34 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
13.9%
47/337 • Number of events 60 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
10.5%
35/332 • Number of events 43 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
28/1003 • Number of events 30 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.2%
31/337 • Number of events 32 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.8%
26/332 • Number of events 32 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.10%
1/1003 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.60%
2/332 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
14/1003 • Number of events 15 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
4.5%
15/337 • Number of events 18 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.4%
18/332 • Number of events 22 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
18/1003 • Number of events 20 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.6%
19/337 • Number of events 22 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
6.0%
20/332 • Number of events 23 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Dizziness
|
3.4%
34/1003 • Number of events 36 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.2%
31/337 • Number of events 35 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.1%
27/332 • Number of events 30 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Dysgeusia
|
2.6%
26/1003 • Number of events 33 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.3%
18/337 • Number of events 20 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
2.4%
8/332 • Number of events 12 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Headache
|
3.6%
36/1003 • Number of events 41 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.6%
29/337 • Number of events 36 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.7%
29/332 • Number of events 34 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
14.3%
1/7 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Nervous system disorders
Paraesthesia
|
0.90%
9/1003 • Number of events 9 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
1.8%
6/337 • Number of events 8 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.6%
12/332 • Number of events 13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/1003 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/332 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
36/1003 • Number of events 36 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.8%
33/337 • Number of events 41 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
11.4%
38/332 • Number of events 48 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
15.4%
2/13 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
54/1003 • Number of events 55 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
26/337 • Number of events 27 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
12.7%
42/332 • Number of events 48 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.90%
9/1003 • Number of events 9 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.6%
12/337 • Number of events 14 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.0%
10/332 • Number of events 15 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
15.4%
2/13 • Number of events 2 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
52/1003 • Number of events 54 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.5%
32/337 • Number of events 38 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
8.7%
29/332 • Number of events 39 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
75/1003 • Number of events 76 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
9.2%
31/337 • Number of events 37 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
11.1%
37/332 • Number of events 43 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.40%
4/1003 • Number of events 4 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/337 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.30%
1/332 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
7.7%
1/13 • Number of events 1 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
|
Vascular disorders
Hypertension
|
2.4%
24/1003 • Number of events 26 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
3.3%
11/337 • Number of events 14 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
5.1%
17/332 • Number of events 18 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/7 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
0.00%
0/13 • Up to ~51 months
All-cause Mortality (ACM): All enrolled participants; AEs: All participants who got ≥1 dose of study drug counted in the latest arm in which a participant got treated. Per protocol ACM and AEs were reported separately for pembrolizumab second course. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER