Trial Outcomes & Findings for This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours) (NCT NCT03604445)

Last Updated: 2024-03-04

Results Overview

The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of \>5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

37 participants

Primary outcome timeframe

In the first treatment cycle, up to 3 weeks

Results posted on

2024-03-04

Participant Flow

This non-randomised, open-label, single arm, dose escalation trial was planned to determine the maximum tolerated dose (MTD) of BI 905677 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905677. Two treatment schedules (A and B) were planned. But only Schedule A was conducted.

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

Participant milestones
Measure	BI 905677 0.05 mg/kg 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Overall Study STARTED	3	3	3	3	3	6	6	7	3
Overall Study COMPLETED	3	3	3	2	3	5	5	6	1
Overall Study NOT COMPLETED	0	0	0	1	0	1	1	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 905677 0.4 mg/kg 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Overall Study Death	0	0	0	0	1
Overall Study Withdrawal by Subject	0	0	1	0	0
Overall Study Missing visit	0	1	0	1	0
Overall Study Adverse Event	1	0	0	0	1

Baseline Characteristics

This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 905677 0.05 mg/kg n=3 Participants 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg n=3 Participants 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg n=3 Participants 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg n=3 Participants 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg n=3 Participants 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg n=6 Participants 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg n=6 Participants 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg n=7 Participants 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg n=3 Participants 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	Total n=37 Participants Total of all reporting groups
Age, Continuous	52.3 Years STANDARD_DEVIATION 17.4 • n=93 Participants	57.7 Years STANDARD_DEVIATION 8.0 • n=4 Participants	54.7 Years STANDARD_DEVIATION 10.0 • n=27 Participants	58.3 Years STANDARD_DEVIATION 10.7 • n=483 Participants	50.7 Years STANDARD_DEVIATION 7.6 • n=36 Participants	58.3 Years STANDARD_DEVIATION 11.3 • n=10 Participants	55.0 Years STANDARD_DEVIATION 10.8 • n=115 Participants	52.3 Years STANDARD_DEVIATION 14.9 • n=40 Participants	64.0 Years STANDARD_DEVIATION 2.6 • n=8 Participants	55.6 Years STANDARD_DEVIATION 11.0 • n=62 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants	4 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=40 Participants	1 Participants n=8 Participants	13 Participants n=62 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants	5 Participants n=115 Participants	3 Participants n=40 Participants	2 Participants n=8 Participants	24 Participants n=62 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	1 Participants n=62 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	3 Participants n=36 Participants	5 Participants n=10 Participants	6 Participants n=115 Participants	7 Participants n=40 Participants	2 Participants n=8 Participants	35 Participants n=62 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	1 Participants n=8 Participants	1 Participants n=62 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=40 Participants	1 Participants n=8 Participants	11 Participants n=62 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	1 Participants n=62 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	1 Participants n=62 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	2 Participants n=36 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	5 Participants n=40 Participants	2 Participants n=8 Participants	24 Participants n=62 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants

PRIMARY outcome

Timeframe: In the first treatment cycle, up to 3 weeks

Population: Maximum Tolerated Dose (MTD) Evaluation Set (MTDS): includes all patients in the treated set who were not replaced for the MTD determination.

Outcome measures

Outcome measures
Measure	BI 905677 0.05 mg/kg n=3 Participants 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg n=3 Participants 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg n=3 Participants 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg n=3 Participants 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg n=3 Participants 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg n=6 Participants 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg n=6 Participants 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg n=6 Participants 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg n=3 Participants 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks.

Population: Treated Set (TS): includes all patients who received at least one infusion of BI 905677.

The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported.

Outcome measures

Outcome measures
Measure	BI 905677 0.05 mg/kg n=3 Participants 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg n=3 Participants 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg n=3 Participants 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg n=3 Participants 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg n=3 Participants 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg n=6 Participants 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg n=6 Participants 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg n=7 Participants 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg n=3 Participants 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period	3 Participants	3 Participants	2 Participants	3 Participants	3 Participants	6 Participants	6 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.

Population: Pharmacokinetics (PK) Analysis Set (PKS): The PK set included all patients in the treated set who provided at least one observation for at least one PK endpoint without important protocol violations relevant to the evaluation of PK. Only participants with non-missing outcomes were included in the analysis.

The Maximum measured concentration of BI 905677 in serum after first infusion is reported.

Outcome measures

Outcome measures
Measure	BI 905677 0.05 mg/kg n=3 Participants 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg n=3 Participants 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg n=2 Participants 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg n=3 Participants 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg n=2 Participants 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg n=6 Participants 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg n=6 Participants 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg n=6 Participants 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg n=3 Participants 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax)	512 nanogram / milliliter Geometric Coefficient of Variation 20.7	1100 nanogram / milliliter Geometric Coefficient of Variation 22.00	1720 nanogram / milliliter Geometric Coefficient of Variation 6.59	4890 nanogram / milliliter Geometric Coefficient of Variation 23.1	6540 nanogram / milliliter Geometric Coefficient of Variation 30.9	13700 nanogram / milliliter Geometric Coefficient of Variation 25.8	23100 nanogram / milliliter Geometric Coefficient of Variation 17.6	26800 nanogram / milliliter Geometric Coefficient of Variation 18.5	47500 nanogram / milliliter Geometric Coefficient of Variation 17.1

SECONDARY outcome

Timeframe: 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.

The Area under the serum concentration-time curve over the time interval from 0 to the last measured time point is reported.

Outcome measures

Outcome measures
Measure	BI 905677 0.05 mg/kg n=3 Participants 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg n=3 Participants 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg n=2 Participants 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg n=3 Participants 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg n=2 Participants 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg n=6 Participants 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg n=6 Participants 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg n=6 Participants 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg n=3 Participants 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz)	8260 nanogram * hour / milliliter Geometric Coefficient of Variation 64.5	26000 nanogram * hour / milliliter Geometric Coefficient of Variation 11.00	49700 nanogram * hour / milliliter Geometric Coefficient of Variation 16.0	144000 nanogram * hour / milliliter Geometric Coefficient of Variation 66.6	258000 nanogram * hour / milliliter Geometric Coefficient of Variation 43.7	694000 nanogram * hour / milliliter Geometric Coefficient of Variation 22.3	1130000 nanogram * hour / milliliter Geometric Coefficient of Variation 10.6	1170000 nanogram * hour / milliliter Geometric Coefficient of Variation 30.4	1950000 nanogram * hour / milliliter Geometric Coefficient of Variation 32.5

Adverse Events

BI 905677 0.05 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

BI 905677 0.1 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

BI 905677 0.2 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

BI 905677 0.4 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

BI 905677 0.8 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

BI 905677 1.6 mg/kg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

BI 905677 2.4 mg/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

BI 905677 2.8 mg/kg

Serious events: 7 serious events

Other events: 7 other events

Deaths: 1 deaths

BI 905677 3.6 mg/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	BI 905677 0.05 mg/kg n=3 participants at risk 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg n=3 participants at risk 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg n=3 participants at risk 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg n=3 participants at risk 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg n=3 participants at risk 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg n=6 participants at risk 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg n=6 participants at risk 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg n=7 participants at risk 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg n=3 participants at risk 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	42.9% 3/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Constipation	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Nausea	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Vomiting	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Asthenia	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Hepatobiliary disorders Liver disorder	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations COVID-19	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Gastroenteritis viral	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Klebsiella sepsis	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Pneumonia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Stoma site infection	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood electrolytes decreased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations C-telopeptide increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Hemiparesis	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Spinal cord compression	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Psychiatric disorders Confusional state	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Vascular disorders Embolism	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Vascular disorders Vena cava thrombosis	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.

Other adverse events

Other adverse events
Measure	BI 905677 0.05 mg/kg n=3 participants at risk 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.1 mg/kg n=3 participants at risk 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.2 mg/kg n=3 participants at risk 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.4 mg/kg n=3 participants at risk 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 0.8 mg/kg n=3 participants at risk 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 1.6 mg/kg n=6 participants at risk 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.4 mg/kg n=6 participants at risk 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 2.8 mg/kg n=7 participants at risk 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.	BI 905677 3.6 mg/kg n=3 participants at risk 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Eye disorders Vitreous floaters	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	50.0% 3/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	50.0% 3/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	57.1% 4/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Ascites	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Constipation	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 4/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	50.0% 3/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	42.9% 3/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Flatulence	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Melaena	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Nausea	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	100.0% 3/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Gastrointestinal disorders Vomiting	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	50.0% 3/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	42.9% 3/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Asthenia	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Chills	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Fatigue	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Infusion site extravasation	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Malaise	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Oedema	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Oedema peripheral	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
General disorders Pyrexia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Hepatobiliary disorders Liver disorder	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Enterocolitis bacterial	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Nasopharyngitis	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Infections and infestations Urinary tract infection	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Alanine aminotransferase increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood bicarbonate decreased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood bilirubin increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood cholesterol increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood creatinine increased	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood magnesium decreased	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood potassium decreased	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood sodium decreased	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Blood triglycerides increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Bone density decreased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations C-telopeptide increased	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations International normalised ratio increased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Neutrophil count decreased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Investigations Weight decreased	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	50.0% 3/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	50.0% 3/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Gout	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	28.6% 2/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Metabolism and nutrition disorders Hypotriglyceridaemia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Dizziness	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Dysgeusia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Headache	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Memory impairment	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Neurotoxicity	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Psychiatric disorders Anxiety	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Psychiatric disorders Confusional state	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Psychiatric disorders Insomnia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	66.7% 2/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Psychiatric disorders Panic attack	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Renal and urinary disorders Dysuria	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Renal and urinary disorders Haematuria	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Renal and urinary disorders Proteinuria	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Renal and urinary disorders Renal impairment	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Reproductive system and breast disorders Genital pain	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Respiratory, thoracic and mediastinal disorders Catarrh	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 1/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	16.7% 1/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	33.3% 2/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Vascular disorders Hypertension	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/6 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	14.3% 1/7 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.	0.00% 0/3 • For adverse events: From first dose until last dose + 42 days (6 weeks) of residual effect period (REP), up to 36 weeks. For all-cause mortality: From first dose through last dose until end of follow-up, up to 30 weeks + 6 months. Treated Set (TS): includes all patients who received at least one infusion of BI 905677.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 18002430127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER