Trial Outcomes & Findings for AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy (NCT NCT02694822)
NCT ID: NCT02694822
Last Updated: 2025-03-17
Results Overview
A DLT was defined as a Grade ≥3 adverse drug reaction (ADR), according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, occurring in the DLT evaluation period (28 days after the initial administration of zalifrelimab). An ADR was defined as all noxious and unintended responses to a medicinal product, related to any dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
Phase 1: Zalifrelimab Dose 1
Participants received zalifrelimab (0.1 milligrams/kilogram \[mg/kg\]) intravenously (IV) every 3 weeks (Q3W).
|
Phase 1: Zalifrelimab Dose 2
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1
STARTED
|
5
|
3
|
10
|
15
|
5
|
0
|
|
Phase 1
Received at Least 1 Dose of Study Drug
|
5
|
3
|
10
|
15
|
5
|
0
|
|
Phase 1
COMPLETED
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Phase 1
NOT COMPLETED
|
4
|
3
|
10
|
14
|
4
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
51
|
|
Phase 2
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
51
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
8
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
43
|
Reasons for withdrawal
| Measure |
Phase 1: Zalifrelimab Dose 1
Participants received zalifrelimab (0.1 milligrams/kilogram \[mg/kg\]) intravenously (IV) every 3 weeks (Q3W).
|
Phase 1: Zalifrelimab Dose 2
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1
Death
|
2
|
1
|
6
|
6
|
3
|
0
|
|
Phase 1
Withdrawal by Subject
|
2
|
2
|
4
|
8
|
1
|
0
|
|
Phase 2
Death
|
0
|
0
|
0
|
0
|
0
|
26
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
13
|
|
Phase 2
Administrative Study Closure
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Phase 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 2
Participant Transferred to Another Site
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy
Baseline characteristics by cohort
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
n=51 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
55 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
73 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
69 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: DLT Evaluable Analysis Set: all participants within the dose escalation (Phase 1) cohorts who received ≥2 doses of zalifrelimab at their assigned dose level and completed the DLT evaluation period of 28 days, or all participants within the dose escalation cohort who received ≥1 dose of zalifrelimab and experienced a DLT. As pre-specified, data were collected and are reported for Phase 1 only.
A DLT was defined as a Grade ≥3 adverse drug reaction (ADR), according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, occurring in the DLT evaluation period (28 days after the initial administration of zalifrelimab). An ADR was defined as all noxious and unintended responses to a medicinal product, related to any dose.
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) of Zalifrelimab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. A treatment-related AE was one in which a causal relationship between the medicinal product and the AE was at least a reasonable possibility and could not be ruled out. 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: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
n=51 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Number of Participants Experiencing Any Treatment-related Adverse Events
|
3 Participants
|
2 Participants
|
6 Participants
|
12 Participants
|
4 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 1 (21 days/cycle)Population: Pharmacokinetics Analysis Set: all participants who received at least 1 dose of zalifrelimab. As pre-specified, data were collected and are reported for Phase 1 only.
Blood samples were collected at designated timepoints to characterize Cmax of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as micrograms/milliliter (ug/mL).
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1: Maximum Drug Concentration (Cmax) of Zalifrelimab
|
1.95 ug/mL
Standard Error 0.30946
|
7.15 ug/mL
Standard Error 1.3635
|
23.1 ug/mL
Standard Error 1.2891
|
63.5 ug/mL
Standard Error 9.4314
|
120 ug/mL
Standard Error 18.075
|
—
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 1 (21 days/cycle)Population: Pharmacokinetics Analysis Set: all participants who received at least 1 dose of zalifrelimab. As pre-specified, data were collected and are reported for Phase 1 only.
Blood samples were collected at designated timepoints to characterize AUC0-21d of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as hour times ug/mL (hour\*ug/mL).
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Drug Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Zalifrelimab
|
317 hour*ug/mL
Standard Error 51.897
|
1522 hour*ug/mL
Standard Error 246.42
|
3915 hour*ug/mL
Standard Error 964.89
|
11390 hour*ug/mL
Standard Error 964.89
|
18803 hour*ug/mL
Standard Error 2370.77
|
—
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). BOR was defined as the best response recorded from the start of treatment until disease progression/recurrence; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters. 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: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
n=51 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Objective Response Rate (ORR)
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 30.9
|
0 percentage of participants
Interval 0.0 to 21.8
|
0 percentage of participants
Interval 0.0 to 52.2
|
5.9 percentage of participants
Interval 2.0 to 15.9
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
DCR was defined as the percentage of participants who had a confirmed response (CR or PR) or stable disease (SD) without progressive disease (PD). 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: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
n=51 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Disease Control Rate (DCR)
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 30.9
|
6.7 percentage of participants
Interval 0.2 to 32.0
|
0 percentage of participants
Interval 0.0 to 52.2
|
37.3 percentage of participants
Interval 25.3 to 51.0
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
DOR was defined as the interval from which the date measurement criteria were met for CR or PR (whichever was first recorded) until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=1 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
n=3 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Duration of Response (DOR)
|
NA weeks
DOR not reached during Phase 1 due to an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
NA weeks
DOR not reached during Phase 2 due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure in Phase 1.
PFS was defined as the interval from the date of first dose of investigational agent until the earliest date of PD, as determined by independent endpoint review committee assessment of objective radiographic disease assessments per RECIST v1.1, or death due to any cause if occurring sooner than progression.
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1: Progression-free Survival (PFS)
|
NA weeks
Interval 3.143 to
Values were non-estimable (insufficient number of participants with events). A lower confidence interval value is reported only since the survival curve crossed 0.5 probability. Only 1 participant experienced the event. The other participants were censored.
|
11.000 weeks
Interval 4.429 to
Values were non-estimable (insufficient number of participants with events).
|
10.429 weeks
Interval 5.286 to 12.429
|
11.143 weeks
Interval 7.143 to 16.286
|
5.714 weeks
Interval 2.571 to
Values were non-estimable (insufficient number of participants with events).
|
—
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
PFS was defined as the interval from the date of first dose of investigational agent until the earliest date of PD, as determined by independent endpoint review committee assessment of objective radiographic disease assessments per RECIST v1.1, or death due to any cause if occurring sooner than progression.
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=51 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 2: PFS
|
2.0 months
Interval 1.4 to 2.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure in Phase 1.
OS was defined as the interval from the date of first dose of investigational agent until the date of death. For participants who did not die, OS was censored at last contact date.
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 Participants
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 Participants
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 Participants
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 Participants
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 1: Overall Survival (OS)
|
NA weeks
Interval 17.429 to
Values were non-estimable (insufficient number of participants with events). A lower confidence interval value is reported only since the survival curve crossed 0.5 probability. Only 2 participants experienced the event. The other participants were censored.
|
71.143 weeks
Values were non-estimable (insufficient number of participants with events). A median value is reported only since the survival curve crossed 0.5 probability. Only 1 participant experienced the event. The other participants were censored.
|
20.429 weeks
Interval 2.0 to 49.857
|
70.571 weeks
Interval 9.857 to
Values were non-estimable (insufficient number of participants with events).
|
15.000 weeks
Interval 4.857 to
Values were non-estimable (insufficient number of participants with events).
|
—
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
OS was defined as the interval from the date of first dose of investigational agent until the date of death. For participants who did not die, OS was censored at last contact date.
Outcome measures
| Measure |
Phase 1: Zalifrelimab Dose 1
n=51 Participants
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Phase 2: OS
|
16.8 months
Interval 5.7 to 25.6
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Zalifrelimab Dose 1
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1: Zalifrelimab Dose 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: Zalifrelimab Dose 3
Serious events: 5 serious events
Other events: 10 other events
Deaths: 6 deaths
Phase 1: Zalifrelimab Dose 4
Serious events: 9 serious events
Other events: 15 other events
Deaths: 6 deaths
Phase 1: Zalifrelimab Dose 5
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Phase 2: Zalifrelimab
Serious events: 23 serious events
Other events: 48 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 participants at risk
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 participants at risk
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 participants at risk
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 participants at risk
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 participants at risk
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
n=51 participants at risk
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Oesophagael obstruction
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Chest pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Asthenia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Fatigue
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
General physical health deterioration
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Blood creatine increased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Eye disorders
Diplopia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
Other adverse events
| Measure |
Phase 1: Zalifrelimab Dose 1
n=5 participants at risk
Participants received zalifrelimab (0.1 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 2
n=3 participants at risk
Participants received zalifrelimab (0.3 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 3
n=10 participants at risk
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 4
n=15 participants at risk
Participants received zalifrelimab (3.0 mg/kg) IV Q3W.
|
Phase 1: Zalifrelimab Dose 5
n=5 participants at risk
Participants received zalifrelimab (6.0 mg/kg) IV Q3W.
|
Phase 2: Zalifrelimab
n=51 participants at risk
Participants received zalifrelimab (1.0 mg/kg) IV Q3W.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
4/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
60.0%
3/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
27.5%
14/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
66.7%
2/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
46.7%
7/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
2/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
25.5%
13/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
4/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
60.0%
3/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
21.6%
11/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
66.7%
2/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
4/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
6/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
17.6%
9/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
3/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
15.7%
8/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
9.8%
5/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Fatigue
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
50.0%
5/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
60.0%
9/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
80.0%
4/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
17/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Pyrexia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
9.8%
5/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
15.7%
8/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Chills
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Chest pain
|
40.0%
2/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Malaise
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
2/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Oedema
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Generalised oedema
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
General disorders
Mass
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
6/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
9.8%
5/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
6/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
6/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Weight decreased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
9.8%
5/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
26.7%
4/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
White blood cell count decreased
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Lymph node palpable
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Investigations
White blood cell count increased
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
21.6%
11/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
11.8%
6/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.7%
7/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
66.7%
2/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
19.6%
10/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
7.8%
4/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.7%
7/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
15.7%
8/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
7.8%
4/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
40.0%
2/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
40.0%
2/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.7%
7/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
7.8%
4/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
11.8%
6/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
15.7%
8/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
3/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
7.8%
4/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Hemiparesis
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Hepatic encephalopathy
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
5/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
17.6%
9/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Abscess soft tissue
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Cystitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Lower respiratory tract infection
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Oral candidiasis
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Infections and infestations
Septic shock
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Urethral obstruction
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
26.7%
4/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
2/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Vascular disorders
Haematoma
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
13.3%
2/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
7.8%
4/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
7.8%
4/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
33.3%
1/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
3.9%
2/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
6.7%
1/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
9.8%
5/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.9%
3/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Cardiac disorders
Cardiac failure
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Eye disorders
Photophobia
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
2.0%
1/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Eye disorders
Eye swelling
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/2 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/2 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/7 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
12.5%
1/8 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
5.3%
1/19 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
10.0%
1/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
20.0%
1/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/3 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/10 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/15 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/5 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
0.00%
0/51 • From Day 1 to the end of study (6 years)
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of zalifrelimab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place