Trial Outcomes & Findings for A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (NCT NCT03516981)
NCT ID: NCT03516981
Last Updated: 2026-06-08
Results Overview
ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by local site radiologic review. The percentage of participants who experience CR or PR as assessed by local site radiologic review with confirmatory assessment per RECIST 1.1 is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
245 participants
Primary outcome timeframe
Up to approximately 80 months
Results posted on
2026-06-08
Participant Flow
Participants were screened for the status of 2 clinically validated, independent next generation biomarkers: T cell-inflamed gene expression profile (GEP) and tumor mutational burden (TMB). Participants were then assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and then randomized to different interventions.
Participant milestones
| Measure |
Pembrolizumab + Lenvatinib
Participants received pembrolizumab 200 mg every 3 weeks (Q3W) intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab
Participants received pembrolizumab 200 mg Q3W IV plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
81
|
83
|
30
|
51
|
|
Overall Study
Treated
|
80
|
82
|
30
|
51
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
81
|
83
|
30
|
51
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Lenvatinib
Participants received pembrolizumab 200 mg every 3 weeks (Q3W) intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab
Participants received pembrolizumab 200 mg Q3W IV plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
0
|
3
|
|
Overall Study
Sponsor Decision
|
9
|
16
|
5
|
12
|
|
Overall Study
Randomized by Mistake Without Study Treatment
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
|
Overall Study
Death
|
69
|
61
|
25
|
34
|
Baseline Characteristics
A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Lenvatinib
n=81 Participants
Participants received pembrolizumab 200 mg every 3 weeks (Q3W) intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab
n=83 Participants
Participants received pembrolizumab 200 mg Q3W IV plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg
n=30 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg
n=51 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
31 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
85 Participants
n=568 Participants
|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 9.4 • n=9 Participants
|
67.3 Years
STANDARD_DEVIATION 9.7 • n=27 Participants
|
62.4 Years
STANDARD_DEVIATION 10.1 • n=267 Participants
|
67.9 Years
STANDARD_DEVIATION 8.4 • n=265 Participants
|
66.2 Years
STANDARD_DEVIATION 9.5 • n=568 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=9 Participants
|
53 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
36 Participants
n=265 Participants
|
160 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
7 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=9 Participants
|
79 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
48 Participants
n=265 Participants
|
230 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
8 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
19 Participants
n=265 Participants
|
74 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=9 Participants
|
52 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
31 Participants
n=265 Participants
|
160 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
|
Biomarker Defined Subgroups
GEP Low / TMB Low
|
25 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
62 Participants
n=568 Participants
|
|
Biomarker Defined Subgroups
GEP Low / TMB High
|
13 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
43 Participants
n=568 Participants
|
|
Biomarker Defined Subgroups
GEP High / TMB Low
|
22 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
22 Participants
n=265 Participants
|
74 Participants
n=568 Participants
|
|
Biomarker Defined Subgroups
GEP High / TMB High
|
21 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
66 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 80 monthsPopulation: All allocated participants who have received study treatment
ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by local site radiologic review. The percentage of participants who experience CR or PR as assessed by local site radiologic review with confirmatory assessment per RECIST 1.1 is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib - GEP Low / TMB Low
n=25 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP Low / TMB High
n=12 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB Low
n=22 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB High
n=21 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab - GEP Low / TMB Low
n=26 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP Low / TMB High
n=13 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB Low
n=22 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB High
n=21 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB Low
n=11 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB High
n=6 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB Low
n=8 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB High
n=5 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP Low / TMB High
n=11 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB Low
n=22 Participants
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB High
n=18 Participants
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
12.0 Percentage of Participants
Interval 2.5 to 31.2
|
33.3 Percentage of Participants
Interval 9.9 to 65.1
|
40.9 Percentage of Participants
Interval 20.7 to 63.6
|
57.1 Percentage of Participants
Interval 34.0 to 78.2
|
11.5 Percentage of Participants
Interval 2.4 to 30.2
|
30.8 Percentage of Participants
Interval 9.1 to 61.4
|
13.6 Percentage of Participants
Interval 2.9 to 34.9
|
52.4 Percentage of Participants
Interval 29.8 to 74.3
|
0.0 Percentage of Participants
Interval 0.0 to 28.5
|
33.3 Percentage of Participants
Interval 4.3 to 77.7
|
25.0 Percentage of Participants
Interval 3.2 to 65.1
|
60.0 Percentage of Participants
Interval 14.7 to 94.7
|
27.3 Percentage of Participants
Interval 6.0 to 61.0
|
13.6 Percentage of Participants
Interval 2.9 to 34.9
|
50.0 Percentage of Participants
Interval 26.0 to 74.0
|
SECONDARY outcome
Timeframe: Up to approximately 80 monthsPopulation: All allocated participants who have received study treatment
PFS was defined as the time from allocation to the first documented progressive disease (PD) or death due to any cause, whichever occurs first according to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by local site radiologic review. PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS for all participants is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib - GEP Low / TMB Low
n=25 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP Low / TMB High
n=12 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB Low
n=22 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB High
n=21 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab - GEP Low / TMB Low
n=26 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP Low / TMB High
n=13 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB Low
n=22 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB High
n=21 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB Low
n=11 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB High
n=6 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB Low
n=8 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB High
n=5 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP Low / TMB High
n=11 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB Low
n=22 Participants
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB High
n=18 Participants
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.4 Months
Interval 2.3 to 8.8
|
13.8 Months
Interval 1.5 to 19.4
|
8.2 Months
Interval 4.2 to 19.7
|
17.8 Months
Interval 6.0 to 20.7
|
2.8 Months
Interval 2.0 to 6.0
|
3.9 Months
Interval 1.9 to 17.3
|
6.1 Months
Interval 2.1 to 12.8
|
17.0 Months
Interval 9.3 to 29.1
|
2.1 Months
Interval 1.9 to 2.1
|
8.1 Months
Interval 1.7 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
2.1 Months
Interval 0.9 to 6.5
|
6.3 Months
Interval 0.4 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
4.2 Months
Interval 1.8 to 12.2
|
3.5 Months
Interval 2.0 to 8.2
|
20.2 Months
Interval 6.1 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 80 monthsPopulation: All allocated participants who have received study treatment
OS was defined as the time from the date of allocation to death due to any cause. The OS for all participants is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib - GEP Low / TMB Low
n=25 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP Low / TMB High
n=12 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB Low
n=22 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB High
n=21 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab - GEP Low / TMB Low
n=26 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP Low / TMB High
n=13 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB Low
n=22 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB High
n=21 Participants
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB Low
n=11 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB High
n=6 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB Low
n=8 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB High
n=5 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP Low / TMB High
n=11 Participants
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB Low
n=22 Participants
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB High
n=18 Participants
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
16.0 Months
Interval 5.4 to 20.2
|
16.9 Months
Interval 3.8 to 33.2
|
22.5 Months
Interval 12.0 to 41.3
|
22.7 Months
Interval 16.9 to 56.0
|
13.3 Months
Interval 8.4 to 20.0
|
20.1 Months
Interval 7.7 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
23.7 Months
Interval 7.9 to 43.1
|
51.6 Months
Interval 17.6 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
8.6 Months
Interval 3.8 to 35.4
|
20.8 Months
Interval 1.7 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
12.6 Months
Interval 0.9 to 25.4
|
NA Months
Interval 13.5 to
NA = Median, Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
18.6 Months
Interval 3.4 to 41.2
|
11.1 Months
Interval 5.2 to 19.6
|
NA Months
Interval 13.0 to
NA = Median, Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 80 monthsPopulation: All allocated participants who have received study treatment
An AE was defined as any untoward medical occurrence in participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants in each treatment arm experiencing an AE is reported.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib - GEP Low / TMB Low
n=80 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP Low / TMB High
n=82 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB Low
n=30 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB High
n=51 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab - GEP Low / TMB Low
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP Low / TMB High
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB Low
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB High
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB Low
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB High
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB Low
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB High
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP Low / TMB High
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB Low
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB High
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
79 Participants
|
78 Participants
|
27 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 39 monthsPopulation: All allocated participants who have received study treatment
An AE was defined as any untoward medical occurrence in participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants in each treatment arm that discontinued study drug due to an AE is reported.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib - GEP Low / TMB Low
n=80 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP Low / TMB High
n=82 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB Low
n=30 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Lenvatinib - GEP High / TMB High
n=51 Participants
Participants received pembrolizumab 200 mg Q3W intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab - GEP Low / TMB Low
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP Low / TMB High
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB Low
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Quavonlimab - GEP High / TMB High
Participants received pembrolizumab 200 mg Q3W (IV) plus quavonlimab 25 mg Q6W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB Low
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP Low / TMB High
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB Low
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg - GEP High / TMB High
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP Low / TMB High
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB Low
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg - GEP High / TMB High
Participants receive pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to AEs
|
34 Participants
|
18 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Pembrolizumab + Lenvatinib
Serious events: 42 serious events
Other events: 76 other events
Deaths: 71 deaths
Pembrolizumab + Quavonlimab
Serious events: 39 serious events
Other events: 75 other events
Deaths: 63 deaths
Pembrolizumab + Favezelimab 200 mg
Serious events: 14 serious events
Other events: 25 other events
Deaths: 25 deaths
Pembrolizumab + Favezelimab 800 mg
Serious events: 31 serious events
Other events: 47 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=80 participants at risk
Participants received pembrolizumab 200 mg every 3 weeks (Q3W) intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab
n=82 participants at risk
Participants received pembrolizumab 200 mg Q3W IV plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg
n=30 participants at risk
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg
n=51 participants at risk
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|
|
General disorders
Death
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/80 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Angina unstable
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Myocardial infarction
|
6.2%
5/80 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Eye disorders
Uveitis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
3/80 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Diverticular perforation
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Asthenia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Chest pain
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Chills
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Condition aggravated
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Discomfort
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Fatigue
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
General physical health deterioration
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Pyrexia
|
2.5%
2/80 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Immune system disorders
Anaphylactic reaction
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Atypical mycobacterial pneumonia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
COVID-19
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
COVID-19 pneumonia
|
3.8%
3/80 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Empyema
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Lung abscess
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pneumonia
|
7.5%
6/80 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.3%
6/82 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pneumonia necrotising
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pulmonary sepsis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Recurrent pyogenic cholangitis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
3/80 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Lipase increased
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Dermatomyositis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Cerebral haematoma
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Seizure
|
1.2%
1/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Disorientation
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
2/80 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Renal impairment
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Surgical and medical procedures
Assisted suicide
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Embolism
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
Other adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=80 participants at risk
Participants received pembrolizumab 200 mg every 3 weeks (Q3W) intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
|
Pembrolizumab + Quavonlimab
n=82 participants at risk
Participants received pembrolizumab 200 mg Q3W IV plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 200 mg
n=30 participants at risk
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
Pembrolizumab + Favezelimab 800 mg
n=51 participants at risk
Participants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
|
|---|---|---|---|---|
|
General disorders
Asthenia
|
32.5%
26/80 • Number of events 30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.4%
11/82 • Number of events 15 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.3%
4/30 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.8%
6/51 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
14.6%
12/82 • Number of events 19 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.8%
6/51 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
15.0%
12/80 • Number of events 12 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
8.5%
7/82 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.8%
6/51 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
36.2%
29/80 • Number of events 34 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
8.5%
7/82 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.3%
4/30 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
19.6%
10/51 • Number of events 11 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
8/80 • Number of events 13 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
6/80 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Constipation
|
28.7%
23/80 • Number of events 32 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.0%
9/82 • Number of events 9 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
20.0%
6/30 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.8%
6/51 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.0%
36/80 • Number of events 60 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
19.5%
16/82 • Number of events 18 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
3/30 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
29.4%
15/51 • Number of events 19 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
7/80 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
4/80 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
4/80 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Nausea
|
27.5%
22/80 • Number of events 30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
15.9%
13/82 • Number of events 14 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.3%
4/30 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
15.7%
8/51 • Number of events 13 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
27.5%
22/80 • Number of events 35 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.1%
5/82 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
20/80 • Number of events 26 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
8/82 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Chest pain
|
3.8%
3/80 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.3%
6/82 • Number of events 12 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Chills
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Fatigue
|
32.5%
26/80 • Number of events 33 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
20.7%
17/82 • Number of events 18 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
21.6%
11/51 • Number of events 15 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Oedema peripheral
|
7.5%
6/80 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
12.2%
10/82 • Number of events 12 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
3/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Pain
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Pyrexia
|
11.2%
9/80 • Number of events 10 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
12.2%
10/82 • Number of events 13 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
23.3%
7/30 • Number of events 9 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
COVID-19
|
7.5%
6/80 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
4/80 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.1%
5/82 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
4/80 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.3%
6/82 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/80 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
16.2%
13/80 • Number of events 17 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
8/82 • Number of events 14 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
19.6%
10/51 • Number of events 13 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Amylase increased
|
7.5%
6/80 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.3%
4/30 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
12/80 • Number of events 19 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
8.5%
7/82 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.7%
7/51 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
11.2%
9/80 • Number of events 9 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
8/82 • Number of events 9 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood bilirubin increased
|
7.5%
6/80 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood creatinine increased
|
7.5%
6/80 • Number of events 12 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Lipase increased
|
10.0%
8/80 • Number of events 11 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Platelet count decreased
|
8.8%
7/80 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Weight decreased
|
26.2%
21/80 • Number of events 22 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
17.1%
14/82 • Number of events 14 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.8%
27/80 • Number of events 34 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
18.3%
15/82 • Number of events 16 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
20.0%
6/30 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.7%
7/51 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
4/80 • Number of events 11 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
3/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
2/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.3%
6/82 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.5%
6/80 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
5/80 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
1/80 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
5/80 • Number of events 10 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
8/80 • Number of events 12 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
8.5%
7/82 • Number of events 14 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
3/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.0%
4/80 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.8%
15/80 • Number of events 26 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.0%
9/82 • Number of events 12 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.3%
4/30 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
15.7%
8/51 • Number of events 11 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.7%
2/30 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
10/80 • Number of events 11 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
8/82 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
5/80 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
1.2%
1/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
5/80 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
5/51 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
6/80 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Dizziness
|
8.8%
7/80 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Dysgeusia
|
8.8%
7/80 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Headache
|
21.2%
17/80 • Number of events 22 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
11.8%
6/51 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Insomnia
|
15.0%
12/80 • Number of events 17 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
14.6%
12/82 • Number of events 12 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.3%
4/30 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
7.8%
4/51 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Proteinuria
|
26.2%
21/80 • Number of events 46 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.7%
3/82 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/51 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
15/80 • Number of events 19 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
22.0%
18/82 • Number of events 20 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
3/30 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
5/51 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
21.2%
17/80 • Number of events 17 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
10/80 • Number of events 11 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.4%
11/82 • Number of events 13 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
10.0%
3/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
17.6%
9/51 • Number of events 9 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.8%
3/80 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.4%
2/82 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.5%
6/80 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.1%
5/82 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
2/80 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
8.5%
7/82 • Number of events 8 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.2%
1/80 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
6.1%
5/82 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.9%
2/51 • Number of events 2 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.2%
13/80 • Number of events 15 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/82 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/30 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
12/80 • Number of events 13 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
29.3%
24/82 • Number of events 28 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
20.0%
6/30 • Number of events 7 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
17.6%
9/51 • Number of events 14 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
15/80 • Number of events 22 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.4%
11/82 • Number of events 16 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
13.3%
4/30 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
5/51 • Number of events 5 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
5/80 • Number of events 6 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
9.8%
8/82 • Number of events 10 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
2.0%
1/51 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hypertension
|
52.5%
42/80 • Number of events 53 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
4.9%
4/82 • Number of events 4 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
3.3%
1/30 • Number of events 1 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
5.9%
3/51 • Number of events 3 • Up to approximately 80 months
All-Cause Mortality included all allocated participants. Serious and Other adverse events (AEs) included all participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity was not directed by the Sponsor, the investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER