Trial Outcomes & Findings for A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (NCT NCT03972150)

NCT ID: NCT03972150

Last Updated: 2025-10-06

Results Overview

Maximum tolerated dose (MTD) of BI 836880 monotherapy (Part 1) and combination therapy of BI 836880 and BI75409 (Part 2). The MTD was defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being equal or above 0.33 (EWOC criterion) during the MTD evaluation period. The analysis of the MTD was based on a Bayesian logistic regression model (BLRM) guided by the escalation with overdose control principle. The estimated probability of a DLT at each dose level from the model was summarized using the following intervals: Underdosing: \[0.00, 0.16) Targeted toxicity: \[0.16, 0.33) Over toxicity: \[0.33, 1.00\]

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: First treatment cycle, the first 21 days following the start of trial medication.
• Results posted on: 2025-10-06

Participant Flow

This was a phase I, open label, uncontrolled, non-randomized, two parts, dose-escalation design trial assessing the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (Pd) of BI 836880 monotherapy, and combination therapy of BI 836880 and BI 754091 in Japanese patients with different types of advanced cancer.

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	Part 1: 360 mg BI 836880 Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 1: 720 mg BI 836880 Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Overall Study STARTED	3	6	3	3	6
Overall Study COMPLETED	0	0	0	1	3
Overall Study NOT COMPLETED	3	6	3	2	3

Reasons for withdrawal

Measure	Part 1: 360 mg BI 836880 Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 1: 720 mg BI 836880 Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Overall Study Adverse Event	0	1	1	0	0
Overall Study Progressive disease	3	5	2	2	3

Baseline Characteristics

A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer

Baseline characteristics by cohort

Measure	Part 1: 360 mg BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 1: 720 mg BI 836880 n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Total n=21 Participants Total of all reporting groups
Age, Continuous	62.7 Years STANDARD_DEVIATION 15.7 • n=5 Participants	54.8 Years STANDARD_DEVIATION 14.7 • n=7 Participants	51.7 Years STANDARD_DEVIATION 12.0 • n=5 Participants	57.3 Years STANDARD_DEVIATION 15.5 • n=4 Participants	62.0 Years STANDARD_DEVIATION 8.8 • n=21 Participants	57.9 Years STANDARD_DEVIATION 12.4 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	13 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: First treatment cycle, the first 21 days following the start of trial medication.

Population: Dose escalation cohort treated set in monotherapy/combination therapy: This patients sets included all patients enrolled in dose escalation cohort of monotherapy/combination therapy who were documented to have administrated at least one dose of study medication and were evaluable for the MTD determination. This set is used for dose finding and MTD determination in Part I/Part II.

Maximum tolerated dose (MTD) of BI 836880 monotherapy (Part 1) and combination therapy of BI 836880 and BI75409 (Part 2). The MTD was defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being equal or above 0.33 (EWOC criterion) during the MTD evaluation period. The analysis of the MTD was based on a Bayesian logistic regression model (BLRM) guided by the escalation with overdose control principle. The estimated probability of a DLT at each dose level from the model was summarized using the following intervals:

Underdosing: [0.00, 0.16) Targeted toxicity: [0.16, 0.33) Over toxicity: [0.33, 1.00]

Outcome measures

Measure	Part 1: Total BI 836880 n=9 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=12 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Maximum Tolerated Dose (MTD) of BI 836880 Monotherapy and Combination Therapy of BI 836880 and BI754091	NA milligram Maximum tolerated dose was not reached as no DLTs were reported during the MTD evaluation period (Cycle 1) in Part 1.	NA milligram Maximum tolerated dose was not reached as no DLTs were reported during the MTD evaluation period (Cycle 1) in Part 2.	—	—	—

PRIMARY outcome

Timeframe: First treatment cycle, the first 21 days following the start of trial medication.

Population: Dose escalation cohort treated set in monotherapy/combination therapy: This patients sets included all patients enrolled in dose escalation cohort of monotherapy/combination therapy who were documented to have administrated at least one dose of study medication and were evaluable for the MTD determination. This set is used for dose finding and MTD determination in Part I/Part II.

Number of participants with DLT occurring during the first treatment cycle. DLT was defined as any of the following adverse events related to the treatment: Haematologic toxicities: -Any Grade 5 toxicity,-Neutropenia Grade 4 lasting for >7 days,-Grade ≥3 documented infection with neutropenia,-Febrile neutropenia (absolute neutrophil count <1.0 X 109 cells/L and fever ≥38.5C or a sustained temperature of ≥38.0 Centigrade (C) for more than 1 hour),-Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding,-Thrombocytopenia of any Grade which requires platelet transfusions,-Grade 4 anaemia unexplained by underlying disease,-Anaemia of any Grade which requires blood transfusions. Non-haematological toxicities: - Aspartate transaminase (AST) or Alanin-Aminotransferase (ALT) >3 times Upper Level of Normal (ULN) and concurrent total bilirubin >2 times ULN without initial findings of cholestasis,-≥ Grade 4 AST or ALT of any duration.

Outcome measures

Measure	Part 1: Total BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part 1(P1): Within 5 minutes(min) before, at 1 hour(h), 1.5h, 2.5h, 4.5h, 7.5h, 24h, 48h, 168h, 336h after Cycle 1 dose. Part 2(P2): Within 5 min before and at 1h, 2h15min, 6h, 24h, 168h, 336h after Cycle 1 dose. P1,P2: Within 5min before Cycle 2 dose.

Population: Pharmacokinetics parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one Pharmacokinetics (PK) parameter that was not excluded.

Maximum measured concentration of BI 836880 at Cycle 1 in Part 1 (monotherapy) and Part 2 (combination therapy) in plasma (Cmax) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Maximum Measured Concentration of BI 836880 in Part 1 and Part 2 in Plasma (Cmax) at Cycle 1	131 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 20.6	281 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 22.7	50.4 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 8.71	121 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 21.6	316 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 21.1

SECONDARY outcome

Timeframe: Part 1(P1): Within 5 minutes(min) before and at 1 hour(h), 1.5h, 2.5h, 4.5h, 7.5h, 24h, 48h, 168h, 336h after Cycle 1 dose. Part 2(P2): Within 5min before and at 1h, 2h15min, 6h, 24h, 168h, 336h after Cycle 1 dose. P1,P2: Within 5min before Cycle 2 dose.

Population: PK parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one Pharmacokinetic (PK) parameter that was not excluded.

Area under the concentration-time curve of BI 836880 in Part 1 (monotherapy) and in Part 2 (combination therapy) in plasma over the time interval from 0 to 504 hours (AUC0-504h) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Area Under the Concentration-time Curve of BI 836880 in Part 1 and Part 2 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) at Cycle 1	22300 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 24.4	50400 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 24.5	8220 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 7.68	21100 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 28.5	50000 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 24.3

SECONDARY outcome

Timeframe: Within 5 minutes (min) before and at 1 hour (h), 1.5h, 2.5h, 4.5h, 7.5h, 24h, 48h, 168h, 336h after dose in Cycle 2. Also, Within 5 min before Cycle 3 dose.

Population: Pharmacokinetics parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded.

Maximum measured concentration of BI 836880 at Cycle 2 in Part 1 (monotherapy) in plasma (Cmax) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Maximum Measured Concentration of BI 836880 in Part 1 in Plasma (Cmax) at Cycle 2	178 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 22.0	319 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 24.0	—	—	—

SECONDARY outcome

Timeframe: Within 5 minutes (min) before and at 1 hour (h), 1.5h, 2.5h, 4.5h, 7.5h, 24h, 48h, 168h, 336h after dose in Cycle 2. Also, Within 5 min before Cycle 3 dose.

Population: PK parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded.

Area under the concentration-time curve of BI 836880 in Part 1 (monotherapy) at Cycle 2 in plasma over the time interval from 0 to 504 hours (AUC0-504h) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Area Under the Concentration-time Curve of BI 836880 in Part 1 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) at Cycle 2	27600 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 31.3	64900 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 36.8	—	—	—

SECONDARY outcome

Timeframe: Part 1(P1): Within 5 minutes (min) before and at 1 hour (h), 1.5h, 2.5h, 4.5h, 7.5h, 24h, 168h, 336h after Cycle 4 dose. Part 2(P2): Within 5min before and at 1 h, 2h15min, 6h, 24h, 168h, 336h after Cycle 4 dose. P1,P2: Within 5min before Cycle 5 dose.

Population: Pharmacokinetics parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded. Only patients with no missing values are reported.

Maximum measured concentration of BI 836880 at Cycle 4 in Part 1 (monotherapy) and Part 2 (combination therapy) in plasma (Cmax) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=2 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Maximum Measured Concentration of BI 836880 in Part 1 and Part 2 in Plasma (Cmax) at Cycle 4	184 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 27.6	621 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 6.83	55.9 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 12.8	159 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 31.6	398 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 32.3

SECONDARY outcome

Timeframe: Part 1(P1): Within 5 minutes (min) before and at 1 hour (h), 1.5h, 2.5h, 4.5h, 7.5h, 24h, 168h, 336h after Cycle 4 dose. Part 2(P2): Within 5min before and at 1 h, 2h15min, 6h, 24h, 168h, 336h after Cycle 4 dose. P1,P2: Within 5min before Cycle 5 dose.

Population: PK parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded. Only patients with no missing values are reported.

Area under the concentration-time curve of BI 836880 in Part 1 (monotherapy) and in Part 2 (combination therapy) at Cycle 4 in plasma over the time interval from 0 to 504 hours (AUC0-504h) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=2 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Area Under the Concentration-time Curve of BI 836880 in Part1 and Part 2 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) at Cycle 4	35500 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 46.6	122000 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 14.2	10600 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 6.81	31400 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 37.4	79100 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 16.4

SECONDARY outcome

Timeframe: Within 5 min before and at 1h, 2h15min, 6h, 24h, 168h, 336h after Cycle 1 dose. Also, Within 5 min before Cycle 2 dose.

Population: Pharmacokinetics parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded.

Maximum measured concentration of Ezabenlimab (BI 754091) at Cycle 1 in Part 2 (combination therapy) in plasma (Cmax) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Maximum Measured Concentration of Ezabenlimab (BI 754091) in Part 2 in Plasma (Cmax) at Cycle 1	83.9 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 6.01	75.3 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 25.4	104 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 19.8	—	—

SECONDARY outcome

Timeframe: Within 5 min before and at 1h, 2h15min, 6h, 24h, 168h, 336h after Cycle 1 dose. Also, Within 5 min before Cycle 2 dose.

Population: PK parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded.

Area under the concentration-time curve of Ezabenlimab (BI 754091) in Part 2 (combination therapy) in plasma over the time interval from 0 to 504 hours (AUC0-504h) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=3 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=6 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Area Under the Concentration-time Curve of Ezabenlimab (BI 754091) in Part 2 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) at Cycle 1	18400 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 5.28	15300 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 23.8	16600 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 26.4	—	—

SECONDARY outcome

Timeframe: Within 5 min before and at 1 h, 2h15min, 6h, 24h, 168h, 336h after dosing in Cycle 4. Also, Within 5 min before Cycle 5 dose.

Population: Pharmacokinetics parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded. Only patients with no missing values are reported.

Maximum measured concentration of Ezabenlimab (BI 754091) at Cycle 4 in Part 2 (combination therapy) in plasma (Cmax) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=2 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Maximum Measured Concentration of Ezabenlimab (BI 754091) in Part 2 in Plasma (Cmax) at Cycle 4	129 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 13.8	106 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 40.2	132 microgram / milliliter (µg/mL) Geometric Coefficient of Variation 37.9	—	—

SECONDARY outcome

Timeframe: Within 5 min before and at 1 h, 2h15min, 6h, 24h, 168h, 336h after dosing in Cycle 4. Also, Within 5 min before Cycle 5 dose.

Population: PK parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the Treated Set (TS) who provide at least one PK parameter that was not excluded. Only patients with no missing values are reported.

Area under the concentration-time curve of Ezabenlimab (BI 754091) in Part 2 (combination therapy) in plasma over the time interval from 0 to 504 hours (AUC0-504h) is reported.

Outcome measures

Measure	Part 1: Total BI 836880 n=2 Participants Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) or 720 mg of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: Total BI 836880/ 240 mg Ezabenlimab n=2 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) or 360 mg or 720 mg of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 Participants Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Area Under the Concentration-time Curve of Ezabenlimab (BI 754091) in Part 2 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) at Cycle 4	32200 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 12.7	22900 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 46.0	27600 hour*microgram/milliliter (h*µg/mL) Geometric Coefficient of Variation 27.1	—	—

Adverse Events

Part 1: 360 mg BI 836880

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: 720 mg BI 836880

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: 360 mg BI 836880 n=3 participants at risk Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 1: 720 mg BI 836880 n=6 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=3 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=6 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
General disorders General physical health deterioration	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system neoplasm	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Nervous system disorders Cerebral infarction	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.

Other adverse events

Measure	Part 1: 360 mg BI 836880 n=3 participants at risk Patients with advanced solid tumors were administered intravenously (i.v.) 360 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 1: 720 mg BI 836880 n=6 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 1).	Part 2: 120 mg of BI 836880/ 240 mg Ezabenlimab n=3 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 120 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 360 mg BI 836880/ 240 mg Ezabenlimab n=3 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 360 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.	Part 2: 720 mg BI 836880 / 240 mg Ezabenlimab n=6 participants at risk Patients with advanced solid tumors were administered intravenously (i. v.) 720 milligram (mg) of BI 836880 solution for infusion and 240 mg Ezabenlimab (BI 754091) solution for infusion on Day 1 of each 3-week cycle until progressive disease, unacceptable toxicity, or other withdrawal criteria were met (Part 2). Part 2 commenced after completion of Part 1.
Investigations Blood creatinine increased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Eye disorders Visual field defect	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Constipation	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Dental caries	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	66.7% 2/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	50.0% 3/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Nausea	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	50.0% 3/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Toothache	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
General disorders Fatigue	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
General disorders Infusion site extravasation	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
General disorders Malaise	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
General disorders Oedema	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
General disorders Oedema peripheral	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
General disorders Pain	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
General disorders Pyrexia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	50.0% 3/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Immune system disorders Seasonal allergy	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Infections and infestations Biliary tract infection	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Infections and infestations Cystitis	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Infections and infestations Nasopharyngitis	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Infections and infestations Periodontitis	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Infections and infestations Pneumonia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Infections and infestations Skin infection	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Injury, poisoning and procedural complications Osteoradionecrosis	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	66.7% 2/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	66.7% 2/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Platelet count decreased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Investigations Weight increased	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Nervous system disorders Somnolence	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Psychiatric disorders Anxiety	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Psychiatric disorders Insomnia	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Renal and urinary disorders Dysuria	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Renal and urinary disorders Proteinuria	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Reproductive system and breast disorders Penile oedema	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.
Vascular disorders Hypertension	33.3% 1/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	33.3% 2/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	100.0% 3/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	0.00% 0/3 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.	16.7% 1/6 • Part I: from first dose till last dose + 42 days, up to 444 + 42 days. Part II: from first dose till last dose + 42 days, up to 672 + 42 days. Treated set (TS) in monotherapy and in combination therapy: This patient set included all patients enrolled in the trial who were documented to have administrated at least one dose of BI 836880 monotherapy or BI 836880 and ezabenlimab (BI 754091) combination therapy.

Additional Information

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