Trial Outcomes & Findings for A Study of AGEN2034 in Advanced Tumors and Cervical Cancer (NCT NCT03104699)
NCT ID: NCT03104699
Last Updated: 2025-07-30
Results Overview
A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
211 participants
Primary outcome timeframe
21 days
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
Phase 1: Balstilimab Dose 1
Participants received 1 milligram/kilogram (mg/kg) every 2 weeks (Q2W) balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg every 3 weeks (Q3W) balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
|
|---|---|---|---|---|---|---|
|
Phase 1: Dose Escalation
STARTED
|
10
|
10
|
10
|
10
|
10
|
0
|
|
Phase 1: Dose Escalation
Received at Least 1 Dose of Study Drug
|
10
|
10
|
10
|
10
|
10
|
0
|
|
Phase 1: Dose Escalation
COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
NOT COMPLETED
|
10
|
10
|
8
|
10
|
10
|
0
|
|
Phase 2: Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
161
|
|
Phase 2: Dose Expansion
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
161
|
|
Phase 2: Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
28
|
|
Phase 2: Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
133
|
Reasons for withdrawal
| Measure |
Phase 1: Balstilimab Dose 1
Participants received 1 milligram/kilogram (mg/kg) every 2 weeks (Q2W) balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg every 3 weeks (Q3W) balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
|
|---|---|---|---|---|---|---|
|
Phase 1: Dose Escalation
Withdrawal by Subject
|
2
|
2
|
4
|
8
|
4
|
0
|
|
Phase 1: Dose Escalation
Physician Decision
|
0
|
0
|
2
|
1
|
0
|
0
|
|
Phase 1: Dose Escalation
Death
|
6
|
3
|
0
|
1
|
1
|
0
|
|
Phase 1: Dose Escalation
Completed Follow Up
|
2
|
2
|
1
|
0
|
2
|
0
|
|
Phase 1: Dose Escalation
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
Progressive Disease
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase 1: Dose Escalation
Disease Progression
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Escalation
Protocol Violation
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Phase 2: Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Phase 2: Dose Expansion
Death
|
0
|
0
|
0
|
0
|
0
|
107
|
|
Phase 2: Dose Expansion
Participant Left to Participate in Another Trial
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 2: Dose Expansion
Administrative Study Closure
|
0
|
0
|
0
|
0
|
0
|
13
|
|
Phase 2: Dose Expansion
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Phase 2: Dose Expansion
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: Balstilimab Dose 1
n=10 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=10 Participants
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=10 Participants
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=10 Participants
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=10 Participants
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 2: Balstilimab Recommended Phase 2 Dose
n=161 Participants
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Adults (18-64 years)
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
119 Participants
n=30 Participants
|
154 Participants
n=3 Participants
|
|
Age, Customized
From 65-84 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
42 Participants
n=30 Participants
|
57 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
161 Participants
n=30 Participants
|
203 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
38 Participants
n=30 Participants
|
43 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
39 Participants
n=30 Participants
|
84 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
84 Participants
n=30 Participants
|
84 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
72 Participants
n=30 Participants
|
113 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Not Reported (France)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
81 Participants
n=30 Participants
|
81 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Romanian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Brown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: DLT Analysis Set: all participants who were enrolled for DLT evaluation (excluding participants enrolled to backfill cohorts) and either received all balstilimab administrations or stopped treatment due to a DLT during the DLT evaluation period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=3 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=6 Participants
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=3 Participants
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=3 Participants
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=3 Participants
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=10 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=10 Participants
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=10 Participants
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=10 Participants
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=10 Participants
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC).
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=160 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC)
|
15.6 percentage of participants
Interval 10.8 to 22.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hours after the first dose (Cycle 1 Day 1) and immediately prior to the second dose (Cycle 2 Day 1) (2-3 weeks/cycle)Population: Receptor Occupancy Analysis Set: all participants who completed ≥1 balstilimab infusion, with adequate measurements of PD-1 receptor occupancy on circulating T cells. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
The percentage of PD-1 receptor occupancy on circulating T cells was measured as an indication of target engagement. An increase in percent occupancy indicates a potential increase in drug effectiveness.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=10 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=5 Participants
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=3 Participants
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 1: Receptor Occupancy of Circulating T Cells
Cycle 1 Day 1
|
73.2 percent occupancy
Standard Deviation 11.95
|
69.4 percent occupancy
Standard Deviation 5.52
|
—
|
76.6 percent occupancy
Standard Deviation 2.95
|
—
|
|
Phase 1: Receptor Occupancy of Circulating T Cells
Cycle 2 Day 1
|
67.7 percent occupancy
Standard Deviation 16.93
|
61.6 percent occupancy
Standard Deviation 1.70
|
—
|
72.1 percent occupancy
Standard Deviation 8.29
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)Population: Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion of study drug and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Blood samples were collected for serum balstilimab concentration determinations. Results are reported as micrograms/milliliter (ug/mL).
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=10 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=9 Participants
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=10 Participants
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=10 Participants
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=10 Participants
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab
Cycle 2 Day 1
|
20.3 ug/mL
Geometric Coefficient of Variation 47.0
|
86.3 ug/mL
Geometric Coefficient of Variation 30.0
|
161 ug/mL
Geometric Coefficient of Variation 27.5
|
239 ug/mL
Geometric Coefficient of Variation 28.2
|
315 ug/mL
Geometric Coefficient of Variation 25.5
|
|
Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab
Cycle 1 Day 1
|
18.1 ug/mL
Geometric Coefficient of Variation 34.3
|
71.9 ug/mL
Geometric Coefficient of Variation 19.5
|
153 ug/mL
Geometric Coefficient of Variation 23.7
|
236 ug/mL
Geometric Coefficient of Variation 26.6
|
282 ug/mL
Geometric Coefficient of Variation 28.4
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)Population: Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Blood samples were collected for serum balstilimab concentration determinations. Results are reported as hours\*micrograms/milliliter (h\*µg/mL).
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=10 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=9 Participants
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=10 Participants
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=10 Participants
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=10 Participants
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab
Cycle 1 Day 1
|
1265 h*µg/mL
Geometric Coefficient of Variation 47.4
|
6470 h*µg/mL
Geometric Coefficient of Variation 34.6
|
12632 h*µg/mL
Geometric Coefficient of Variation 51.5
|
22294 h*µg/mL
Geometric Coefficient of Variation 47.5
|
30751 h*µg/mL
Geometric Coefficient of Variation 50.4
|
|
Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab
Cycle 2 Day 1
|
1477 h*µg/mL
Geometric Coefficient of Variation 73.7
|
7725 h*µg/mL
Geometric Coefficient of Variation 40.2
|
17479 h*µg/mL
Geometric Coefficient of Variation 49.4
|
21298 h*µg/mL
Geometric Coefficient of Variation 47.1
|
42266 h*µg/mL
Geometric Coefficient of Variation 41.0
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
Blood samples were collected for serum balstilimab ADA determination.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=10 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=10 Participants
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=10 Participants
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=10 Participants
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=10 Participants
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=161 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Number of Participants Experiencing TEAEs
|
161 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)Population: Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Blood samples were collected for serum balstilimab concentration determinations. Results are reported in μg/mL.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=124 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Cmax of Balstilimab
Cycle 1 Day 1
|
55.4 μg/mL
Geometric Coefficient of Variation 42.8
|
—
|
—
|
—
|
—
|
|
Phase 2: Cmax of Balstilimab
Cycle 2 Day 1
|
56.6 μg/mL
Geometric Coefficient of Variation 23.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)Population: Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Blood samples were collected for serum balstilimab concentration determinations. Results are reported in day\*μg/mL.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=124 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: AUC0-last of Balstilimab
Cycle 1 Day 1
|
174 day*μg/mL
Geometric Coefficient of Variation 46.3
|
—
|
—
|
—
|
—
|
|
Phase 2: AUC0-last of Balstilimab
Cycle 2 Day 1
|
184 day*μg/mL
Geometric Coefficient of Variation 59.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
Blood samples were collected for serum balstilimab ADA determination.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=161 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Serum ADAs for Balstilimab
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline.
ORR was defined as percentage of participants with a BOR of CR or PR, as determined by the investigator per RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=160 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: ORR as Determined by the Investigator
|
14.4 percentage of participants
Interval 9.8 to 20.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure.
DOR was defined as time from first observation of response to first observation of documented progressive disease (PD) (or death within 12 weeks after last tumor assessment), per RECIST 1.1 and as determined by an IERC and the investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=25 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR)
IERC
|
NA months
Interval 7.3 to
The upper bound of the 95% confidence interval of the median could not be estimated as the median was not reached at the data cut-off.
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Investigator
|
NA months
Interval 8.9 to
The upper bound of the 95% confidence interval of the median could not be estimated as the median was not reached at the data cut-off.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC).
DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) for at least 12 weeks. CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=160 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Disease Control Rate (DCR) as Determined by an IERC
|
50.6 percentage of participants
Interval 43.0 to 58.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC).
TCR was defined as percentage of participants who had a BOR of either SD or a confirmed objective response (CR or PR). CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=160 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Tumor Control Rate (TCR) as Determined by an IERC
|
52.5 percentage of participants
Interval 44.8 to 60.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
TTR was defined as the time from the first dose date to first observation of confirmed response.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=25 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Time to Response (TTR) as Determined by an IERC
|
82.0 days
Interval 60.5 to 108.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure.
PFS was defined as time from first treatment administration to first observation of documented PD (or death within 12 weeks after last tumor assessment), per RECIST 1.1, as determined by an IERC and investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=137 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Progression-free Survival (PFS)
IERC
|
2.8 months
Interval 2.4 to 3.9
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS)
Investigator
|
3.6 months
Interval 2.7 to 4.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure.
OS was defined as time from start of treatment to death. For participants who were still alive at the time of data cutoff for trial analysis or who were lost to follow-up, survival was censored at the last recorded date that the participant was known to have been alive as of the cutoff date for analysis.
Outcome measures
| Measure |
Phase 1: Balstilimab Dose 1
n=108 Participants
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
|---|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
11.2 months
Interval 9.5 to 14.5
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Balstilimab Dose 1
Serious events: 5 serious events
Other events: 10 other events
Deaths: 6 deaths
Phase 1: Balstilimab Dose 2
Serious events: 3 serious events
Other events: 10 other events
Deaths: 3 deaths
Phase 1: Balstilimab Dose 3
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 1: Balstilimab Dose 4
Serious events: 3 serious events
Other events: 10 other events
Deaths: 1 deaths
Phase 1: Balstilimab Dose 5
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Phase 2: Balstilimab Recommended Phase 2 Dose
Serious events: 90 serious events
Other events: 158 other events
Deaths: 108 deaths
Serious adverse events
| Measure |
Phase 1: Balstilimab Dose 1
n=10 participants at risk
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=10 participants at risk
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=10 participants at risk
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=10 participants at risk
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=10 participants at risk
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 2: Balstilimab Recommended Phase 2 Dose
n=161 participants at risk
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
General physical health deterioration
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Fatigue
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Oedema
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Cardiac disorders
Cardiopulmonary failure
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Colonic fistula
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Upper GI haemorrhage
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
4.3%
7/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.7%
6/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Postrenal failure
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Impetigo
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Device related infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Arboviral infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Septic shock
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
Other adverse events
| Measure |
Phase 1: Balstilimab Dose 1
n=10 participants at risk
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 2
n=10 participants at risk
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 3
n=10 participants at risk
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 4
n=10 participants at risk
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
|
Phase 1: Balstilimab Dose 5
n=10 participants at risk
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
|
Phase 2: Balstilimab Recommended Phase 2 Dose
n=161 participants at risk
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
40.0%
4/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
50.0%
5/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
29.2%
47/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
28.0%
45/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
40.0%
4/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
25.5%
41/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
50.0%
5/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
23.6%
38/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
21.7%
35/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
6.8%
11/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Asthenia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
34.8%
56/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Fatigue
|
70.0%
7/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
40.0%
4/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
70.0%
7/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
23.0%
37/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
21.7%
35/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
13.0%
21/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
7/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
40.0%
4/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
49.7%
80/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
8.1%
13/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
22.4%
36/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
13.7%
22/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
11.8%
19/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
8.7%
14/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
7.5%
12/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.6%
9/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
21.7%
35/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
50.0%
5/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
50.0%
5/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
21.1%
34/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
11.8%
19/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
9.3%
15/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
8.1%
13/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
6.2%
10/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.6%
17/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.6%
17/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.6%
17/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
9.9%
16/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Weight decreased
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
9.9%
16/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
8.1%
13/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.6%
9/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
19.3%
31/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
4/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
14.3%
23/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
18.6%
30/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
6.2%
10/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.6%
9/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
16.1%
26/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
6.2%
10/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.6%
9/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.6%
9/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
15.5%
25/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
12.5%
1/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
9.9%
16/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
9.9%
16/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
9.3%
15/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
6.8%
11/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Endocrine disorders
Immune-mediated hypothyroidism
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.6%
9/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.6%
9/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.0%
8/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.0%
8/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.7%
6/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Lip erythema
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
4.3%
7/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Chills
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Oedema
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Malaise
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Catheter site pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
General disorders
Early satiety
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
4.3%
7/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
4.3%
7/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Cystitis
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Candida infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Fungal infection
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Impetigo
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Investigations
International normalised ratio increased
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
40.0%
4/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.0%
3/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
5.0%
8/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
4.3%
7/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.1%
5/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.7%
6/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Nephritis
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Renal and urinary disorders
Urinary tract pain
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/2 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
50.0%
1/2 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/1 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
100.0%
1/1 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/2 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
—
0/0 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/9 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
12.5%
1/8 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Psychiatric disorders
Depression
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.7%
6/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Psychiatric disorders
Irritability
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
2.5%
4/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Embolism
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Cardiac disorders
Bradycardia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.2%
2/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Injury, poisoning and procedural complications
Stoma site irritation
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
1.9%
3/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.62%
1/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
10.0%
1/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
0.00%
0/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
20.0%
2/10 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
3.7%
6/161 • From Day 1 to the end of study (3 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place