Trial Outcomes & Findings for A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061) (NCT NCT02370498)
NCT ID: NCT02370498
Last Updated: 2022-06-06
Results Overview
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval \[CI\]) in months was reported for PD-L1 positive participants by treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
592 participants
Primary outcome timeframe
Up to 30 months (through database cut-off date of 26 Oct 2017)
Results posted on
2022-06-06
Participant Flow
After 20 March 2016, enrollment was limited to programmed cell death ligand 1 (PD-L1) positive participants.
Of 592 participants that were randomized to trial, 570 received treatment. At the time of the primary analysis data cut-off, 89 participants are ongoing in the study.
Participant milestones
| Measure |
Pembrolizumab
Participants receive 200 mg intravenous (IV) pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
296
|
296
|
|
Overall Study
Treated
|
294
|
276
|
|
Overall Study
PD-L1 Positive Participants
|
196
|
199
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
296
|
296
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Participants receive 200 mg intravenous (IV) pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
8
|
|
Overall Study
Death
|
263
|
265
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
12
|
|
Overall Study
Sponsor's decision
|
15
|
9
|
Baseline Characteristics
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Total
n=592 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 Years
STANDARD_DEVIATION 12.0 • n=39 Participants
|
59.6 Years
STANDARD_DEVIATION 11.7 • n=41 Participants
|
60.2 Years
STANDARD_DEVIATION 11.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=39 Participants
|
88 Participants
n=41 Participants
|
182 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=39 Participants
|
208 Participants
n=41 Participants
|
410 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
269 Participants
n=39 Participants
|
272 Participants
n=41 Participants
|
541 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
93 Participants
n=39 Participants
|
91 Participants
n=41 Participants
|
184 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
193 Participants
n=39 Participants
|
198 Participants
n=41 Participants
|
391 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Europe/Israel/North America/Australia
|
190 Participants
n=39 Participants
|
187 Participants
n=41 Participants
|
377 Participants
n=35 Participants
|
|
Region of Enrollment
Asia
|
88 Participants
n=39 Participants
|
89 Participants
n=41 Participants
|
177 Participants
n=35 Participants
|
|
Region of Enrollment
Rest of World
|
18 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
PD-L1 Status
Positive
|
196 Participants
n=39 Participants
|
199 Participants
n=41 Participants
|
395 Participants
n=35 Participants
|
|
PD-L1 Status
Negative
|
99 Participants
n=39 Participants
|
96 Participants
n=41 Participants
|
195 Participants
n=35 Participants
|
|
PD-L1 Status
Unknown
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Time To Progression (TTP) on first-line therapy
<6 months
|
186 Participants
n=39 Participants
|
182 Participants
n=41 Participants
|
368 Participants
n=35 Participants
|
|
Time To Progression (TTP) on first-line therapy
≥6 months
|
110 Participants
n=39 Participants
|
114 Participants
n=41 Participants
|
224 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval \[CI\]) in months was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
|
1.5 months
Interval 1.4 to 2.0
|
4.1 months
Interval 3.1 to 4.2
|
PRIMARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) in PD-L1 Positive Participants
|
9.1 months
Interval 6.2 to 10.7
|
8.3 months
Interval 7.6 to 9.0
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS According to RECIST 1.1 Based on BICR in All Participants
|
1.5 months
Interval 1.4 to 1.6
|
4.1 months
Interval 3.2 to 4.2
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
OS in All Participants
|
6.7 months
Interval 5.4 to 8.9
|
8.3 months
Interval 7.7 to 8.8
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
|
1.6 months
Interval 1.5 to 2.7
|
3.1 months
Interval 2.8 to 4.0
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS According to RECIST 1.1 Based on Investigator Assessment in All Participants
|
1.6 months
Interval 1.5 to 1.9
|
3.2 months
Interval 2.9 to 4.0
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated stable disease (SD; neither sufficient shrinkage or increase of target lesion), partial response (PR; ≥30% decrease in the SOD of target lesions), or complete response (CR; disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS According to Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) Based on BICR in PD-L1 Positive Participants
|
1.9 months
Interval 1.4 to 3.0
|
4.2 months
Interval 3.5 to 4.4
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated SD (neither sufficient shrinkage or increase of target lesion), PR (≥30% decrease in the SOD of target lesions), or CR (disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS According to irRECIST Based on BICR in All Participants
|
1.6 months
Interval 1.5 to 2.5
|
4.2 months
Interval 4.0 to 4.4
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to Tumor Progression (TTP) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants
|
1.6 months
Interval 1.4 to 2.7
|
4.0 months
Interval 3.1 to 4.2
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
TTP According to RECIST 1.1 Based on BICR in All Participants
|
1.5 months
Interval 1.4 to 1.8
|
4.1 months
Interval 3.2 to 4.2
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
TTP According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
|
2.1 months
Interval 1.5 to 3.0
|
3.3 months
Interval 2.9 to 4.1
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of \>5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
TTP According to RECIST 1.1 Based on Investigator Assessment in All Participants
|
1.6 months
Interval 1.5 to 2.7
|
3.8 months
Interval 3.0 to 4.1
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate (ORR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants
|
15.8 Percentage of participants
Interval 11.0 to 21.7
|
13.6 Percentage of participants
Interval 9.1 to 19.1
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
ORR According to RECIST 1.1 Based on BICR in All Participants
|
11.1 Percentage of participants
Interval 7.8 to 15.3
|
12.5 Percentage of participants
Interval 9.0 to 16.8
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=196 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=199 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
ORR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
|
17.3 Percentage of participants
Interval 12.3 to 23.4
|
15.6 Percentage of participants
Interval 10.8 to 21.4
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: All randomized participants. Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=296 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=296 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
ORR According to RECIST 1.1 Based on Investigator Assessment in All Participants
|
12.2 Percentage of participants
Interval 8.7 to 16.4
|
15.2 Percentage of participants
Interval 11.3 to 19.8
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized.
For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=31 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=27 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response (DOR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants
|
18.0 months
Interval 1.4 to 26.0
|
5.2 months
Interval 1.3 to 16.8
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized.
For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=33 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=37 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
DOR According to RECIST 1.1 Based on BICR in All Participants
|
18.0 months
Interval 1.4 to 26.0
|
5.5 months
Interval 1.3 to 17.7
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized.
For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=34 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=31 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
DOR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants
|
15.7 months
Interval 2.7 to 23.7
|
4.3 months
Interval 1.8 to 19.1
|
SECONDARY outcome
Timeframe: Up to 30 months (through database cut-off date of 26 Oct 2017)Population: The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized.
For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=36 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=45 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
DOR According to RECIST 1.1 Based on Investigator Assessment in All Participants
|
15.7 months
Interval 2.7 to 23.7
|
4.3 months
Interval 1.3 to 19.1
|
SECONDARY outcome
Timeframe: Up to 71 months (through database cut-off date of 10 Jun 2021)Population: All randomized PD-L1 positive participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=194 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=188 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of PD-L1 Positive Participants Who Experienced an Adverse Event (AE)
|
93.3 Percentage of participants
|
97.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 71 months (through database cut-off date of 10 Jun 2021)Population: All randomized participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=294 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=276 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of All Participants Who Experienced an AE
|
93.9 Percentage of participants
|
97.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 26.4 monthsPopulation: All randomized PD-L1 positive participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for PD-L1 positive participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=194 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=188 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of PD-L1 Positive Participants That Discontinued Study Treatment Due to AE
|
4.1 Percentage of participants
|
8.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 26.4 monthsPopulation: All randomized participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for all participants by treatment group.
Outcome measures
| Measure |
Pembrolizumab
n=294 Participants
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=276 Participants
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of All Participants That Discontinued Study Treatment Due to AE
|
4.8 Percentage of participants
|
9.1 Percentage of participants
|
Adverse Events
Pembrolizumab First Course
Serious events: 108 serious events
Other events: 256 other events
Deaths: 278 deaths
Paclitaxel
Serious events: 68 serious events
Other events: 260 other events
Deaths: 287 deaths
Pembrolizumab Second Course
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pembrolizumab First Course
n=294 participants at risk
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=276 participants at risk
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Pembrolizumab Second Course
n=3 participants at risk
Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
11/294 • Number of events 14 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.8%
5/276 • Number of events 6 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Addison's disease
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypopituitarism
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Cataract
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Retinal detachment
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
8/294 • Number of events 9 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.4%
4/276 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
4/294 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
1.4%
4/294 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.1%
3/276 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
5/294 • Number of events 5 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.4%
4/276 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric hypomotility
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrosplenic fistula
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
1.4%
4/294 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.4%
4/276 • Number of events 7 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Subileus
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.0%
3/294 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
6/294 • Number of events 6 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Complication associated with device
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Death
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
General physical health deterioration
|
1.0%
3/294 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Influenza like illness
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
1.7%
5/294 • Number of events 7 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.4%
4/276 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholangitis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bacterial sepsis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Biliary sepsis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infection
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.1%
3/276 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Medical device site infection
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Otitis media
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
3.1%
9/294 • Number of events 9 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
7/276 • Number of events 8 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.1%
3/276 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
4/294 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Intracranial mass
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Product Issues
Device dislocation
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Product Issues
Device occlusion
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Completed suicide
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
3/294 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal injury
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
3/294 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.0%
3/294 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.4%
4/276 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Shock haemorrhagic
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Vascular compression
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab First Course
n=294 participants at risk
Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years).
|
Paclitaxel
n=276 participants at risk
Participants receive paclitaxel 80 mg/m\^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Pembrolizumab Second Course
n=3 participants at risk
Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.0%
44/294 • Number of events 56 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
24.6%
68/276 • Number of events 86 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
5/294 • Number of events 5 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.2%
31/276 • Number of events 62 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
7.5%
22/294 • Number of events 25 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.8%
17/294 • Number of events 17 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.3%
12/276 • Number of events 12 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
40/294 • Number of events 42 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.8%
49/276 • Number of events 57 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
17/294 • Number of events 21 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.8%
16/276 • Number of events 17 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
6.5%
19/294 • Number of events 19 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.3%
12/276 • Number of events 14 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
56/294 • Number of events 62 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
19.2%
53/276 • Number of events 71 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
40/294 • Number of events 42 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
26.1%
72/276 • Number of events 104 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
18/294 • Number of events 18 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.0%
11/276 • Number of events 13 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
19/294 • Number of events 20 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.2%
17/276 • Number of events 22 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Melaena
|
2.0%
6/294 • Number of events 6 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
22.1%
65/294 • Number of events 75 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
27.9%
77/276 • Number of events 119 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.68%
2/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
7/294 • Number of events 7 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.9%
19/276 • Number of events 22 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
49/294 • Number of events 59 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.0%
47/276 • Number of events 65 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
10.2%
30/294 • Number of events 41 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.8%
38/276 • Number of events 63 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
26.2%
77/294 • Number of events 95 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
32.2%
89/276 • Number of events 132 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
0.68%
2/294 • Number of events 4 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.8%
16/276 • Number of events 19 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
8.2%
24/294 • Number of events 25 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.5%
29/276 • Number of events 37 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
10.9%
32/294 • Number of events 40 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.9%
30/276 • Number of events 38 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
7/294 • Number of events 9 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.2%
17/276 • Number of events 21 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
18/294 • Number of events 19 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.5%
18/276 • Number of events 26 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
8.2%
24/294 • Number of events 26 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.8%
16/276 • Number of events 22 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
21/294 • Number of events 21 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.3%
9/276 • Number of events 12 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
0.68%
2/294 • Number of events 5 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.0%
36/276 • Number of events 70 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
7.5%
22/294 • Number of events 23 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.2%
17/276 • Number of events 21 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
1.0%
3/294 • Number of events 6 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.9%
19/276 • Number of events 45 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.9%
76/294 • Number of events 83 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
28.6%
79/276 • Number of events 99 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
7/294 • Number of events 8 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 21 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.5%
19/294 • Number of events 20 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.2%
6/276 • Number of events 7 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.1%
15/294 • Number of events 17 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.6%
10/276 • Number of events 11 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
23/294 • Number of events 29 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.7%
24/276 • Number of events 46 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
33/294 • Number of events 37 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.3%
23/276 • Number of events 29 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.34%
1/294 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.36%
1/276 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
9/294 • Number of events 10 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.1%
25/276 • Number of events 31 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
4.8%
14/294 • Number of events 15 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.4%
15/276 • Number of events 18 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
3.4%
10/294 • Number of events 12 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.4%
15/276 • Number of events 20 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.7%
8/294 • Number of events 8 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.2%
42/276 • Number of events 45 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.7%
5/294 • Number of events 5 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.4%
37/276 • Number of events 43 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
5.4%
16/294 • Number of events 16 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.7%
24/276 • Number of events 26 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
18/294 • Number of events 18 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.1%
28/276 • Number of events 34 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
25/294 • Number of events 27 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.9%
19/276 • Number of events 22 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.72%
2/276 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.34%
1/294 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
42.0%
116/276 • Number of events 120 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/294 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/276 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.9%
29/294 • Number of events 29 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.5%
18/276 • Number of events 25 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.9%
29/294 • Number of events 34 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.0%
22/276 • Number of events 30 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/3 • Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER