Trial Outcomes & Findings for This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment. (NCT NCT03156114)
NCT ID: NCT03156114
Last Updated: 2026-01-26
Results Overview
The MTD is defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being above 33%. DLTs include: Haematologic toxicities: * Any Grade 5 toxicity * Neutropenia ≥ Grade 4 for \>5 days * Any duration febrile neutropenia * Grade 4 thrombocytopenia or Grade 3 with bleeding/platelet transfusion need * Unexplained Grade 4 anaemia. Non-haematological toxicities: * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x Upper limit of normal (ULN) and total bilirubin \>2x ULN without cholestasis signs * ≥Grade 4 AST or ALT of any duration * Any ≥Grade 3 non-haematologic toxicity with exceptions * Any Grade 4 or 5 adverse event (AE) * Any Grade 2 pneumonitis * Any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment * Any ≥ Grade 2 toxicity causing inability to administer BI 754091 on Cycle 2 Day 1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
172 participants
Primary outcome timeframe
First treatment cycle, the first 21 days following the start of trial medication.
Results posted on
2026-01-26
Participant Flow
This was an an open label, Phase I dose-finding study in patients with advanced solid cancers followed by expansion cohorts at the selected dose of the combination in patients with non-small cell lung cancer and other solid tumors.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose-Expansion Cohort G
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with 2nd and 3rd line Non-small cell lung cancer (NSCLC) who progressed on anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) treatment.
|
Dose-Expansion Cohort H
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in ≥2nd line microsatellite stable anti-PD-1 and anti-PD-L1 treatment-naïve metastatic colorectal cancer (mCRC).
|
Dose-Expansion Cohort I
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with any solid tumour with high tumour mutational burden (TMB) and/or microsatellite instability high (MSI-H) and/or DNA mismatch repair deficient solid tumours who have received 1 prior anti-PD-1 or anti-PD-L1 treatment regimen.
|
Dose-Expansion Cohort J
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) patients with 1st line epidermal growth factor receptor (EGFR) wildtype (WT) and anaplastic lymphoma kinase (ALK) wildtype NSCLC. Patients may have any level of PD-L1 expression, but only a maximum of 10 patients with PD-L1 high expression (≥50% PD-L1) were enrolled.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
9
|
9
|
9
|
9
|
6
|
21
|
40
|
39
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
9
|
9
|
9
|
9
|
6
|
21
|
40
|
39
|
17
|
Reasons for withdrawal
| Measure |
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose-Expansion Cohort G
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with 2nd and 3rd line Non-small cell lung cancer (NSCLC) who progressed on anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) treatment.
|
Dose-Expansion Cohort H
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in ≥2nd line microsatellite stable anti-PD-1 and anti-PD-L1 treatment-naïve metastatic colorectal cancer (mCRC).
|
Dose-Expansion Cohort I
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with any solid tumour with high tumour mutational burden (TMB) and/or microsatellite instability high (MSI-H) and/or DNA mismatch repair deficient solid tumours who have received 1 prior anti-PD-1 or anti-PD-L1 treatment regimen.
|
Dose-Expansion Cohort J
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) patients with 1st line epidermal growth factor receptor (EGFR) wildtype (WT) and anaplastic lymphoma kinase (ALK) wildtype NSCLC. Patients may have any level of PD-L1 expression, but only a maximum of 10 patients with PD-L1 high expression (≥50% PD-L1) were enrolled.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
4
|
8
|
8
|
5
|
8
|
6
|
5
|
17
|
31
|
27
|
7
|
|
Overall Study
Other than listed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Subject decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
2
|
|
Overall Study
Non-compliant with study drug
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
2
|
0
|
3
|
1
|
3
|
7
|
5
|
4
|
|
Overall Study
Currently on treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.
Baseline characteristics by cohort
| Measure |
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose-Expansion Cohort G
n=21 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with 2nd and 3rd line Non-small cell lung cancer (NSCLC) who progressed on anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) treatment.
|
Dose-Expansion Cohort H
n=40 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in ≥2nd line microsatellite stable anti-PD-1 and anti-PD-L1 treatment-naïve metastatic colorectal cancer (mCRC).
|
Dose-Expansion Cohort I
n=39 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with any solid tumour with high tumour mutational burden (TMB) and/or microsatellite instability high (MSI-H) and/or DNA mismatch repair deficient solid tumours who have received 1 prior anti-PD-1 or anti-PD-L1 treatment regimen.
|
Dose-Expansion Cohort J
n=17 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) patients with 1st line epidermal growth factor receptor (EGFR) wildtype (WT) and anaplastic lymphoma kinase (ALK) wildtype NSCLC. Patients may have any level of PD-L1 expression, but only a maximum of 10 patients with PD-L1 high expression (≥50% PD-L1) were enrolled.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 9.7 • n=41 Participants
|
62.3 years
STANDARD_DEVIATION 10.8 • n=1581 Participants
|
61.8 years
STANDARD_DEVIATION 5.5 • n=4626 Participants
|
59.6 years
STANDARD_DEVIATION 19.2 • n=72 Participants
|
59.9 years
STANDARD_DEVIATION 9.6
|
54.2 years
STANDARD_DEVIATION 6.2 • n=140 Participants
|
60.2 years
STANDARD_DEVIATION 14.2 • n=58 Participants
|
66.1 years
STANDARD_DEVIATION 7.9 • n=12 Participants
|
55.4 years
STANDARD_DEVIATION 13.0 • n=12 Participants
|
64.6 years
STANDARD_DEVIATION 11.1 • n=12 Participants
|
71.5 years
STANDARD_DEVIATION 9.0 • n=12 Participants
|
61.9 years
STANDARD_DEVIATION 12.1 • n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
6 Participants
n=72 Participants
|
3 Participants
|
5 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
8 Participants
n=12 Participants
|
13 Participants
n=12 Participants
|
22 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
81 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
6 Participants
|
4 Participants
n=140 Participants
|
4 Participants
n=58 Participants
|
13 Participants
n=12 Participants
|
27 Participants
n=12 Participants
|
17 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
91 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
|
1 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
9 Participants
n=72 Participants
|
7 Participants
|
8 Participants
n=140 Participants
|
4 Participants
n=58 Participants
|
20 Participants
n=12 Participants
|
38 Participants
n=12 Participants
|
36 Participants
n=12 Participants
|
15 Participants
n=12 Participants
|
158 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
|
0 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
1 Participants
|
1 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
6 Participants
n=72 Participants
|
6 Participants
|
8 Participants
n=140 Participants
|
4 Participants
n=58 Participants
|
20 Participants
n=12 Participants
|
36 Participants
n=12 Participants
|
34 Participants
n=12 Participants
|
16 Participants
n=12 Participants
|
151 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: First treatment cycle, the first 21 days following the start of trial medication.Population: The MTD evaluation set included all patients in the dose escalation cohort who received BI 754111 or ezabenlimab, and who were not replaced within the MTD evaluation period (First treatment cycle, the first 21 days following the start of trial medication).
The MTD is defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being above 33%. DLTs include: Haematologic toxicities: * Any Grade 5 toxicity * Neutropenia ≥ Grade 4 for \>5 days * Any duration febrile neutropenia * Grade 4 thrombocytopenia or Grade 3 with bleeding/platelet transfusion need * Unexplained Grade 4 anaemia. Non-haematological toxicities: * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x Upper limit of normal (ULN) and total bilirubin \>2x ULN without cholestasis signs * ≥Grade 4 AST or ALT of any duration * Any ≥Grade 3 non-haematologic toxicity with exceptions * Any Grade 4 or 5 adverse event (AE) * Any Grade 2 pneumonitis * Any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment * Any ≥ Grade 2 toxicity causing inability to administer BI 754091 on Cycle 2 Day 1.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=55 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Maximum-tolerated Dose (MTD) of the BI 754111 Plus Ezabenlimab Combination
|
—
|
NA Milligram
There were no dose-limiting toxicities experienced by any dose escalation cohort patient during the MTD evaluation period, thus MTD was not reached.
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First treatment cycle, the first 21 days following the start of trial medication.Population: The MTD evaluation set included all patients in the dose escalation cohort who received BI 754111 or ezabenlimab, and who were not replaced within the MTD evaluation period (First treatment cycle, the first 21 days following the start of trial medication).
Number of patients experiencing DLTs during the combination MTD evaluation period (first cycle of BI 754111 plus ezabenlimab combination therapy) in patients with solid tumours.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Patients Experiencing DLTs During the Combination MTD Evaluation Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 818 days.Population: The Treated Set (TS) included all patients in the dose expansion cohort who received at least 1 dose of BI 754111 or ezabenlimab and had a post baseline measurement.
Dose expansion: Number of patients with objective response (OR) - confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 as assessed by the Investigator during the entire treatment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=18 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=36 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=37 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=15 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Expansion: Number of Patients With Objective Response (OR) - Confirmed Complete Response (CR) and Partial Response (PR)
|
—
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.Population: The Treated Set (TS) included all patients in the dose escalation cohort who received at least 1 dose of BI 754111 or ezabenlimab and had a post baseline measurement.
Dose escalation: Number of patients with objective response (OR) - confirmed complete response (CR) and partial response (PR) according to RECIST Version 1.1 as assessed by the Investigator during the entire treatment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=7 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=8 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Patients With Objective Response (OR) - Confirmed Complete Response (CR) and Partial Response (PR)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.Population: The Treated Set (TS) included all patients in the dose escalation cohort who received at least 1 dose of BI 754111 or ezabenlimab and had a post baseline measurement.
Dose escalation: Number of patients experiencing DLTs from start of treatment until end of treatment (in all cycles).
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Patients Experiencing DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the date of objective response until first date that recurrent or PD has been documented, up to 100 weeks.Population: The Treated Set (TS) included all patients in the dose expansion cohort who received at least 1 dose of BI 754111 or ezabenlimab and had a post baseline measurement and had an objective response.
Duration of response is measured from the time measurements criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=3 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=4 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=3 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Expansion: Duration of Response
|
—
|
—
|
41.14 Weeks
Standard Deviation 31.74
|
45.93 Weeks
Standard Deviation 31.37
|
21.57 Weeks
Standard Deviation 49.22
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 818 days.Population: The Treated Set (TS) included all patients in the dose expansion cohort who received at least 1 dose of BI 754111 or ezabenlimab and had a post baseline measurement.
Dose expansion: Percentage of patients with disease control (CR, PR, or stable disease (SD) according to RECIST Version 1.1) as assessed by the Investigator.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=18 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=36 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=37 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=15 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Expansion: Percentage of Patients With Disease Control
|
—
|
44.4 Percentage of participants
Interval 21.5 to 69.2
|
38.9 Percentage of participants
Interval 23.1 to 56.5
|
43.2 Percentage of participants
Interval 27.1 to 60.5
|
86.7 Percentage of participants
Interval 59.5 to 98.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 818 days.Population: The Treated Set (TS) included all patients in the dose expansion cohort who received at least 1 dose of BI 754111 or ezabenlimab and had a post baseline measurement.
Dose expansion: Progression-free survival (PFS) is defined as time from first drug intake until disease progression or death from any cause, whichever occurs earlier. The date of progression will be based on the Investigator assessment according to RECIST 1.1. For patients with 'event' as an outcome for PFS: • PFS \[days\] = date of outcome - date of start of treatment + 1 For patients with 'censored' as an outcome for PFS: • PFS (censored) \[days\] = date of outcome - date of start of treatment + 1 Days were converted into months for reporting.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=21 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=40 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=39 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=17 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Expansion: Progression-free Survival (PFS)
|
—
|
2.3 Months
Interval 1.4 to 5.7
|
1.4 Months
Interval 1.3 to 2.8
|
1.5 Months
Interval 1.3 to 4.1
|
5.5 Months
Interval 2.7 to 13.7
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 818 days.Population: The Treated Set (TS) included all patients in the dose expansion cohort who received at least 1 dose of BI 754111 or ezabenlimab and had a post baseline measurement.
Dose expansion: Number of patients experiencing DLTs from start of treatment until end of treatment.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=21 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=40 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=39 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=17 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Expansion: Number of Patients Experiencing DLTs
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the first treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one Pharmacokinetic (PK) endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data were included.
Dose escalation: AUC0-504: area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=3 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=8 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: AUC0-504: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours
|
14300 microgram*hours/milliliter
Geometric Coefficient of Variation 31.0
|
12300 microgram*hours/milliliter
Geometric Coefficient of Variation 19.3
|
15700 microgram*hours/milliliter
Geometric Coefficient of Variation 17.6
|
14300 microgram*hours/milliliter
Geometric Coefficient of Variation 16.8
|
15500 microgram*hours/milliliter
Geometric Coefficient of Variation 33.0
|
13600 microgram*hours/milliliter
Geometric Coefficient of Variation 16.3
|
15600 microgram*hours/milliliter
Geometric Coefficient of Variation 24.7
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the fourth treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data were included.
Dose escalation: AUC0-504 steady state: area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours at steady state.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=3 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=1 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=2 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=1 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=6 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=4 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=3 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: AUC0-504 Steady State: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours
|
35200 microgram*hours/milliliter
Geometric Coefficient of Variation 11.2
|
NA microgram*hours/milliliter
Geometric Coefficient of Variation na
Parameter could not be calculated for less than 2 subjects
|
23800 microgram*hours/milliliter
Geometric Coefficient of Variation 31.1
|
NA microgram*hours/milliliter
Geometric Coefficient of Variation na
Parameter could not be calculated for less than 2 subjects
|
27800 microgram*hours/milliliter
Geometric Coefficient of Variation 29.1
|
27000 microgram*hours/milliliter
Geometric Coefficient of Variation 36.4
|
22400 microgram*hours/milliliter
Geometric Coefficient of Variation 41.2
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the first treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data who had enough data to calculate the endpoint were included.
Dose escalation: AUC0-504: area under the concentration-time curve of BI 754111 in plasma over the time interval from 0 to 504 hours.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=7 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: AUC0-504: Area Under the Concentration-time Curve of BI 754111 in Plasma Over the Time Interval From 0 to 504 Hours
|
38100 microgram*hours/milliliter
Geometric Coefficient of Variation 30.4
|
NA microgram*hours/milliliter
Geometric Coefficient of Variation NA
below the level of detection
|
NA microgram*hours/milliliter
Geometric Coefficient of Variation NA
below the level of detection
|
3180 microgram*hours/milliliter
Geometric Coefficient of Variation 19.9
|
10000 microgram*hours/milliliter
Geometric Coefficient of Variation 31.8
|
18500 microgram*hours/milliliter
Geometric Coefficient of Variation 19.5
|
30700 microgram*hours/milliliter
Geometric Coefficient of Variation 28.1
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the fourth treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data who had enough data to calculate the endpoint were included.
Dose escalation: AUC0-504 steady state: area under the concentration-time curve of BI 754111 in plasma over the time interval from 0 to 504 hours at steady state.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=3 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=1 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=2 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=1 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=6 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=4 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=3 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: AUC0-504 Steady State: Area Under the Concentration-time Curve of BI 754111 in Plasma Over the Time Interval From 0 to 504 Hours
|
83500 microgram*hours/milliliter
Geometric Coefficient of Variation 3.58
|
NA microgram*hours/milliliter
Geometric Coefficient of Variation NA
Parameter could not be calculated for less than 2 subjects.
|
NA microgram*hours/milliliter
Geometric Coefficient of Variation NA
below the level of detection
|
NA microgram*hours/milliliter
Geometric Coefficient of Variation na
Parameter could not be calculated for less than 2 subjects.
|
14300 microgram*hours/milliliter
Geometric Coefficient of Variation 35.6
|
25600 microgram*hours/milliliter
Geometric Coefficient of Variation 42.7
|
44900 microgram*hours/milliliter
Geometric Coefficient of Variation 32.4
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the first treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data were included.
Dose escalation: Cmax: maximum measured concentration of ezabenlimab in plasma over the time interval from 0 to 504 hours.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Cmax: Maximum Measured Concentration of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours
|
75.9 microgram/milliliter
Geometric Coefficient of Variation 12.2
|
67.2 microgram/milliliter
Geometric Coefficient of Variation 29.5
|
76.8 microgram/milliliter
Geometric Coefficient of Variation 19.7
|
69.9 microgram/milliliter
Geometric Coefficient of Variation 24.0
|
85.5 microgram/milliliter
Geometric Coefficient of Variation 56.9
|
71.2 microgram/milliliter
Geometric Coefficient of Variation 17.6
|
76.2 microgram/milliliter
Geometric Coefficient of Variation 20.6
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the fourth treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data were included.
Dose escalation: Cmax steady state: maximum measured concentration of ezabenlimab in plasma over the time interval from 0 to 504 hours at steady state.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=5 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=1 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=2 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=6 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=6 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=5 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=3 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Cmax Steady State: Maximum Measured Concentration of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours
|
102 microgram/milliliter
Geometric Coefficient of Variation 26.9
|
NA microgram/milliliter
Geometric Coefficient of Variation na
Parameter could not be calculated for less than 2 subjects
|
90.6 microgram/milliliter
Geometric Coefficient of Variation 26.6
|
96.3 microgram/milliliter
Geometric Coefficient of Variation 28.2
|
108 microgram/milliliter
Geometric Coefficient of Variation 31.3
|
110 microgram/milliliter
Geometric Coefficient of Variation 20.5
|
94.2 microgram/milliliter
Geometric Coefficient of Variation 44.9
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the first treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data were included.
Dose escalation: Cmax: maximum measured concentration of BI 754111 in plasma over the time interval from 0 to 504 hours.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Cmax: Maximum Measured Concentration of BI 754111 in Plasma Over the Time Interval From 0 to 504 Hours
|
232 microgram/milliliter
Geometric Coefficient of Variation 19.8
|
1.05 microgram/milliliter
Geometric Coefficient of Variation 23.5
|
6.23 microgram/milliliter
Geometric Coefficient of Variation 15.7
|
23.5 microgram/milliliter
Geometric Coefficient of Variation 20.7
|
67.9 microgram/milliliter
Geometric Coefficient of Variation 53.9
|
114 microgram/milliliter
Geometric Coefficient of Variation 23.8
|
177 microgram/milliliter
Geometric Coefficient of Variation 26.6
|
SECONDARY outcome
Timeframe: Within 1 hour before and 1, 4, 7, 24, 72, 168, 336 and 504 hours following the start of infusion in the fourth treatment cycle.Population: All patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Only patients in the dose escalation cohort with non-missing data were included.
Dose escalation: Cmax steady state: maximum measured concentration of BI 754111 in plasma over the time interval from 0 to 504 hours at steady state.
Outcome measures
| Measure |
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=5 Participants
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=1 Participants
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=2 Participants
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=6 Participants
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=6 Participants
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=5 Participants
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=3 Participants
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation: Cmax Steady State: Maximum Measured Concentration of BI 754111 in Plasma Over the Time Interval From 0 to 504 Hours
|
294 microgram/milliliter
Geometric Coefficient of Variation 23.1
|
NA microgram/milliliter
Geometric Coefficient of Variation na
Parameter could not be calculated for less than 2 subjects
|
3.98 microgram/milliliter
Geometric Coefficient of Variation 0.711
|
26.5 microgram/milliliter
Geometric Coefficient of Variation 18.0
|
72.2 microgram/milliliter
Geometric Coefficient of Variation 31.6
|
142 microgram/milliliter
Geometric Coefficient of Variation 24.2
|
220 microgram/milliliter
Geometric Coefficient of Variation 32.5
|
Adverse Events
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
Serious events: 1 serious events
Other events: 9 other events
Deaths: 3 deaths
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
Serious events: 1 serious events
Other events: 9 other events
Deaths: 2 deaths
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
Serious events: 4 serious events
Other events: 9 other events
Deaths: 2 deaths
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
Serious events: 2 serious events
Other events: 9 other events
Deaths: 3 deaths
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose-Expansion Cohort G
Serious events: 8 serious events
Other events: 18 other events
Deaths: 16 deaths
Dose-Expansion Cohort H
Serious events: 16 serious events
Other events: 39 other events
Deaths: 27 deaths
Dose-Expansion Cohort I
Serious events: 21 serious events
Other events: 36 other events
Deaths: 25 deaths
Dose-Expansion Cohort J
Serious events: 8 serious events
Other events: 16 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 participants at risk
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 participants at risk
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 participants at risk
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 participants at risk
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 participants at risk
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 participants at risk
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose-Expansion Cohort G
n=21 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with 2nd and 3rd line Non-small cell lung cancer (NSCLC) who progressed on anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) treatment.
|
Dose-Expansion Cohort H
n=40 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in ≥2nd line microsatellite stable anti-PD-1 and anti-PD-L1 treatment-naïve metastatic colorectal cancer (mCRC).
|
Dose-Expansion Cohort I
n=39 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with any solid tumour with high tumour mutational burden (TMB) and/or microsatellite instability high (MSI-H) and/or DNA mismatch repair deficient solid tumours who have received 1 prior anti-PD-1 or anti-PD-L1 treatment regimen.
|
Dose-Expansion Cohort J
n=17 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) patients with 1st line epidermal growth factor receptor (EGFR) wildtype (WT) and anaplastic lymphoma kinase (ALK) wildtype NSCLC. Patients may have any level of PD-L1 expression, but only a maximum of 10 patients with PD-L1 high expression (=50% PD-L1) were enrolled.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Clostridium test positive
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue haemorrhage
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
Other adverse events
| Measure |
Dose Escalation Cohort: BI 754111 4 mg + 240 mg Ezabenlimab
n=4 participants at risk
4 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 20 mg + 240 mg Ezabenlimab
n=9 participants at risk
20 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 80 mg + 240 mg Ezabenlimab
n=9 participants at risk
80 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 200 mg + 240 mg Ezabenlimab
n=9 participants at risk
200 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 400 mg + 240 mg Ezabenlimab
n=9 participants at risk
400 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 600 mg + 240 mg Ezabenlimab
n=9 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose Escalation Cohort: BI 754111 800 mg + 240 mg Ezabenlimab
n=6 participants at risk
800 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w).
|
Dose-Expansion Cohort G
n=21 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with 2nd and 3rd line Non-small cell lung cancer (NSCLC) who progressed on anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) treatment.
|
Dose-Expansion Cohort H
n=40 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in ≥2nd line microsatellite stable anti-PD-1 and anti-PD-L1 treatment-naïve metastatic colorectal cancer (mCRC).
|
Dose-Expansion Cohort I
n=39 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) in patients with any solid tumour with high tumour mutational burden (TMB) and/or microsatellite instability high (MSI-H) and/or DNA mismatch repair deficient solid tumours who have received 1 prior anti-PD-1 or anti-PD-L1 treatment regimen.
|
Dose-Expansion Cohort J
n=17 participants at risk
600 milligram (mg) BI 754111 and 240 mg ezabenlimab given as an intravenous infusion on day 1 of 21-day cycles (q3w) patients with 1st line epidermal growth factor receptor (EGFR) wildtype (WT) and anaplastic lymphoma kinase (ALK) wildtype NSCLC. Patients may have any level of PD-L1 expression, but only a maximum of 10 patients with PD-L1 high expression (=50% PD-L1) were enrolled.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Endocrine disorders
Goitre
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
2/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
12.5%
5/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
15.0%
6/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
12.8%
5/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.5%
7/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
44.4%
4/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
30.0%
12/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.1%
9/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.5%
4/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
55.6%
5/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
19.0%
4/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.5%
7/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.9%
7/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
29.4%
5/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
20.0%
8/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
20.5%
8/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.5%
4/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Asthenia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Catheter site rash
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Chest pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Chills
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
15.0%
6/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Fatigue
|
75.0%
3/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
44.4%
4/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
50.0%
3/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
28.6%
6/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
40.0%
16/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
43.6%
17/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.5%
4/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Feeling cold
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Malaise
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Oedema
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.8%
5/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.5%
9/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
12.8%
5/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
20.5%
8/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
12.5%
5/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.0%
4/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
20.0%
8/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
15.0%
6/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Troponin increased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.5%
4/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
19.0%
4/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.5%
7/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
28.2%
11/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
29.4%
5/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
2/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
20.5%
8/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
29.4%
5/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.5%
9/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.9%
7/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.5%
4/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.5%
7/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.5%
7/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
23.5%
4/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.0%
4/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.0%
4/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
15.4%
6/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Product issues
Device malfunction
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.0%
4/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
14.3%
3/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
20.0%
8/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
19.0%
4/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
12.5%
5/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
10.3%
4/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
9.5%
2/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.9%
1/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
2/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
12.5%
5/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.9%
7/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.5%
3/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.8%
2/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.1%
2/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
33.3%
3/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
16.7%
1/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
5.0%
2/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
22.2%
2/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.6%
1/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
4.8%
1/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
11.1%
1/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/9 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
0.00%
0/6 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
19.0%
4/21 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
2.5%
1/40 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
7.7%
3/39 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
17.6%
3/17 • From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period), up to 1286 days.
The Treated Set (TS) included all patients who received at least 1 dose of BI 754111 or ezabenlimab.
|
Additional Information
Boehringer Ingelheim , Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER