Trial Outcomes & Findings for Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) (NCT NCT05446870)
NCT ID: NCT05446870
Last Updated: 2025-10-01
Results Overview
Blood samples were collected to determine levels of ctDNA. The fold change in the mean mutant/tumor molecules per mL (MTM/mL) at Cycle 3 from baseline is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Baseline and Week 7
Results posted on
2025-10-01
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
Treated
|
79
|
80
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
61
|
62
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Overall Study
Death
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
52
|
53
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Only participants with detectable ctDNA at baseline were included.
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=80 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=80 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 9.5 • n=80 Participants
|
61.5 Years
STANDARD_DEVIATION 10.2 • n=80 Participants
|
60.8 Years
STANDARD_DEVIATION 9.9 • n=160 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=80 Participants
|
80 Participants
n=80 Participants
|
160 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=80 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=80 Participants
|
10 Participants
n=80 Participants
|
27 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=80 Participants
|
68 Participants
n=80 Participants
|
131 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=80 Participants
|
2 Participants
n=80 Participants
|
2 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=80 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=80 Participants
|
24 Participants
n=80 Participants
|
37 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=80 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=80 Participants
|
1 Participants
n=80 Participants
|
2 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=80 Participants
|
54 Participants
n=80 Participants
|
120 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=80 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=80 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=160 Participants
|
|
Detectable Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA)
|
214.4 MTM/mL
STANDARD_DEVIATION 421.9 • n=64 Participants • Only participants with detectable ctDNA at baseline were included.
|
233.9 MTM/mL
STANDARD_DEVIATION 393.2 • n=68 Participants • Only participants with detectable ctDNA at baseline were included.
|
224.5 MTM/mL
STANDARD_DEVIATION 405.9 • n=132 Participants • Only participants with detectable ctDNA at baseline were included.
|
PRIMARY outcome
Timeframe: Baseline and Week 7Population: All randomized participants who received at least one dose of study intervention, had detectable ctDNA at baseline, and had assessed ctDNA at Cycle 3.
Blood samples were collected to determine levels of ctDNA. The fold change in the mean mutant/tumor molecules per mL (MTM/mL) at Cycle 3 from baseline is presented.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=51 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=63 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)
|
0.08 Fold change
Standard Deviation 0.24
|
0.04 Fold change
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least one dose of study intervention, had surgery, and had pCR and ctDNA data available for assessment.
Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. Per protocol, change from baseline in ctDNA in participants with surgery and pCR was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=39 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=53 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA
|
0.05 Fold Change
Standard Deviation 0.13
|
0.04 Fold Change
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least one dose of study intervention, had surgery, and had pCR and ctDNA data available for assessment.
Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. pCR rate was defined as percentage of participants with pCR. Per protocol, the association of change from baseline in ctDNA with pCR in participants with surgery and pCR was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=39 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=53 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Association of Change From Baseline in ctDNA With pCR
|
12.8 Percentage of Participants
Interval 4.3 to 27.4
|
11.3 Percentage of Participants
Interval 4.3 to 23.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least one dose of study intervention, had surgery, and had CRS and ctDNA data available for assessment.
Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. Per protocol, change from baseline in ctDNA in participants with surgery and CRS was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=35 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=52 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA
|
0.09 Fold Change
Standard Deviation 0.28
|
0.04 Fold Change
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least one dose of study intervention, had surgery, and had CRS and ctDNA data available for assessment.
Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, the association of change from baseline in ctDNA with CRS3 in participants with surgery and CRS was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=35 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=52 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Association of Change From Baseline in ctDNA With CRS3
|
45.7 Percentage of Participants
Interval 28.8 to 63.4
|
23.1 Percentage of Participants
Interval 12.5 to 36.8
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeksPopulation: All randomized participants who received at least one dose of study intervention, received surgery, and had pCR data available for assessment.
pCR rate was defined as the percentage of participants with all surgical specimens collected during the interval debulking surgery that were microscopically negative for residual tumor. The pCR rate as assessed by local pathologist was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=58 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=65 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
pCR Rate
|
10.3 Percentage of Participants
Interval 3.9 to 21.2
|
9.2 Percentage of Participants
Interval 3.5 to 19.0
|
SECONDARY outcome
Timeframe: Up to approximately 12 weeksPopulation: All randomized participants who received at least one dose of study intervention, received surgery, and had CRS data available for assessment.
CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, CRS3 rate as assessed by local pathologist was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=55 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=61 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
CRS3 Rate
|
43.6 Percentage of Participants
Interval 30.3 to 57.7
|
23.0 Percentage of Participants
Interval 13.2 to 35.5
|
SECONDARY outcome
Timeframe: Up to approximately 26 monthsPopulation: All randomized participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=79 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=80 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
77 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 28 weeksPopulation: All randomized participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study intervention due to an AE was reported.
Outcome measures
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=79 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=80 Participants
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Intervention Due to an AE
|
13 Participants
|
15 Participants
|
Adverse Events
Pembrolizumab + Standard of Care (SOC) + MK-4830
Serious events: 28 serious events
Other events: 75 other events
Deaths: 6 deaths
Pembrolizumab + SOC
Serious events: 33 serious events
Other events: 79 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=79 participants at risk
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=80 participants at risk
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.5%
2/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
3/79 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.0%
4/80 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Eye disorders
Vision blurred
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.0%
4/80 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.8%
3/80 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.5%
2/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Faecaloma
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.0%
4/80 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.5%
2/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Superior mesenteric artery syndrome
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/79 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Fatigue
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Pyrexia
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.8%
3/80 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Serositis
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Abdominal infection
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Device related infection
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Enterocolitis infectious
|
1.3%
1/79 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Peritoneal abscess
|
1.3%
1/79 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Peritonitis bacterial
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Post procedural infection
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Sepsis
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.5%
2/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Sialoadenitis
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Neutrophil count decreased
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.8%
3/80 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Platelet count decreased
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary serous endometrial carcinoma
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Syncope
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.5%
2/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
3/79 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
2/79 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
2/79 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/80 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
2/79 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.5%
2/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.3%
1/79 • Number of events 1 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/80 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
Other adverse events
| Measure |
Pembrolizumab + Standard of Care (SOC) + MK-4830
n=79 participants at risk
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), carboplatin, and MK-4830 by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
Pembrolizumab + SOC
n=80 participants at risk
Before surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants received pembrolizumab, paclitaxel (or docetaxel), and carboplatin (with avastin \[or biosimilar\] at the investigator's discretion and per institutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
55.7%
44/79 • Number of events 57 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
66.2%
53/80 • Number of events 92 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.7%
14/79 • Number of events 34 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
15.0%
12/80 • Number of events 16 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.6%
21/79 • Number of events 47 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
23.8%
19/80 • Number of events 29 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.2%
12/79 • Number of events 16 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.8%
11/80 • Number of events 14 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.5%
6/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
11.4%
9/79 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.2%
5/80 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.1%
19/79 • Number of events 21 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
23.8%
19/80 • Number of events 29 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Constipation
|
36.7%
29/79 • Number of events 38 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
30.0%
24/80 • Number of events 30 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.0%
15/79 • Number of events 19 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
23.8%
19/80 • Number of events 24 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
3/79 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.5%
6/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Nausea
|
38.0%
30/79 • Number of events 36 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
43.8%
35/80 • Number of events 47 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
3.8%
3/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
8/80 • Number of events 8 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
11/79 • Number of events 16 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
22.5%
18/80 • Number of events 23 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Asthenia
|
20.3%
16/79 • Number of events 29 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
25.0%
20/80 • Number of events 21 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Fatigue
|
25.3%
20/79 • Number of events 23 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
20.0%
16/80 • Number of events 17 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Oedema peripheral
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.2%
5/80 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Pyrexia
|
13.9%
11/79 • Number of events 13 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
15.0%
12/80 • Number of events 17 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Immune system disorders
Drug hypersensitivity
|
3.8%
3/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.2%
5/80 • Number of events 7 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
COVID-19
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.2%
9/80 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Urinary tract infection
|
10.1%
8/79 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.2%
13/80 • Number of events 16 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.5%
2/79 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.2%
5/80 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.5%
13/79 • Number of events 14 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
26.2%
21/80 • Number of events 21 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
9/79 • Number of events 10 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.2%
13/80 • Number of events 16 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
10.1%
8/79 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
20.0%
16/80 • Number of events 20 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.9%
7/79 • Number of events 7 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.2%
9/80 • Number of events 10 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Lymphocyte count decreased
|
5.1%
4/79 • Number of events 7 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.2%
9/80 • Number of events 11 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Neutrophil count decreased
|
13.9%
11/79 • Number of events 20 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
26.2%
21/80 • Number of events 41 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Platelet count decreased
|
10.1%
8/79 • Number of events 11 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
26.2%
21/80 • Number of events 30 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Weight decreased
|
7.6%
6/79 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
15.0%
12/80 • Number of events 13 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
White blood cell count decreased
|
7.6%
6/79 • Number of events 14 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.2%
13/80 • Number of events 20 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.4%
9/79 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.2%
13/80 • Number of events 13 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
4/79 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.0%
4/80 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
20.0%
16/80 • Number of events 27 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.8%
3/79 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.8%
11/80 • Number of events 16 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.2%
12/79 • Number of events 17 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
21.2%
17/80 • Number of events 26 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.1%
8/79 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.8%
11/80 • Number of events 13 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.5%
2/79 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.8%
11/80 • Number of events 18 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.7%
14/79 • Number of events 20 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.8%
11/80 • Number of events 19 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
6/79 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.8%
3/80 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.0%
15/79 • Number of events 17 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.8%
11/80 • Number of events 11 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.8%
3/80 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Dizziness
|
6.3%
5/79 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.2%
5/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Dysgeusia
|
6.3%
5/79 • Number of events 8 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.5%
6/80 • Number of events 10 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Headache
|
8.9%
7/79 • Number of events 7 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
8/80 • Number of events 10 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.3%
20/79 • Number of events 20 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
35.0%
28/80 • Number of events 37 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Neurotoxicity
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.0%
4/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Paraesthesia
|
8.9%
7/79 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.8%
3/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.3%
5/79 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.2%
9/80 • Number of events 9 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Anxiety
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.5%
2/80 • Number of events 2 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Insomnia
|
6.3%
5/79 • Number of events 5 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
8/80 • Number of events 8 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
3/79 • Number of events 3 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.5%
6/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
4/79 • Number of events 7 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
12.5%
10/80 • Number of events 12 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.3%
35/79 • Number of events 36 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
48.8%
39/80 • Number of events 40 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.7%
10/79 • Number of events 14 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.5%
6/80 • Number of events 8 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.0%
15/79 • Number of events 20 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
28.7%
23/80 • Number of events 30 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.2%
5/80 • Number of events 10 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hot flush
|
0.00%
0/79 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.5%
6/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hypertension
|
5.1%
4/79 • Number of events 4 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.5%
6/80 • Number of events 6 • Up to approximately 26 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
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