Trial Outcomes & Findings for A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread (NCT NCT03166631)

Last Updated: 2024-11-19

Results Overview

Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being above 33% during the MTD evaluation period.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

62 participants

Primary outcome timeframe

First treatment cycle (MTD evaluation period), up to 21 days.

Results posted on

2024-11-19

Participant Flow

An open-label trial to investigate the maximum tolerated dose (MTD)/recommended dose for further development based on dose limiting toxicities (DLT), safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BI 891065 alone and in combination with BI 754091 in patients with advanced and/or metastatic malignancies.

Only patients that met all inclusion and none of the exclusion criteria were included in this trial. Prior to the initiation of any trial-related procedure, all patients were informed about the trial verbally and in writing by the investigator. Patients who discontinued from trial medication are reported as not completed.

Participant milestones

Participant milestones
Measure	Part A: 5 mg BI 891065 1 film-coated tablet of 5 milligram (mg) of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part B: 50 mg BI 891065 QD + 240 mg BI 754091 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 QD + 240 mg BI 754091 4 film-coated tablets of 50 mg, or 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 400 mg BI 891065 QD + 240 mg BI 754091 4 film-coated tablets of 100 mg (400 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 BID + 240 mg BI 754091 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally twice daily (BID) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.
Overall Study STARTED	3	1	3	4	3	3	8	6	14	8	9
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	1	3	4	3	3	8	6	14	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: 5 mg BI 891065 1 film-coated tablet of 5 milligram (mg) of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part B: 50 mg BI 891065 QD + 240 mg BI 754091 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 QD + 240 mg BI 754091 4 film-coated tablets of 50 mg, or 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 400 mg BI 891065 QD + 240 mg BI 754091 4 film-coated tablets of 100 mg (400 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 BID + 240 mg BI 754091 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally twice daily (BID) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.
Overall Study Progressive disease	2	1	3	4	2	2	5	6	11	5	7
Overall Study Physician Decision	0	0	0	0	0	0	1	0	1	0	1
Overall Study Death	0	0	0	0	1	0	1	0	0	0	0
Overall Study Adverse Event	1	0	0	0	0	1	1	0	1	2	1
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	0	1	1	0

Baseline Characteristics

A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: 5 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 milligram (mg) of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=4 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 n=3 Participants 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 Participants 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=8 Participants 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part B: 50 mg BI 891065 QD + 240 mg BI 754091 n=6 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 QD + 240 mg BI 754091 n=14 Participants 4 film-coated tablets of 50 mg, or 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 400 mg BI 891065 QD + 240 mg BI 754091 n=8 Participants 4 film-coated tablets of 100 mg (400 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 BID + 240 mg BI 754091 n=9 Participants 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally twice daily (BID) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Total n=62 Participants Total of all reporting groups
Age, Continuous	76.0 Years STANDARD_DEVIATION 2.6 • n=5 Participants	58.0 Years STANDARD_DEVIATION NA • n=7 Participants	65.7 Years STANDARD_DEVIATION 5.5 • n=5 Participants	70.8 Years STANDARD_DEVIATION 9.5 • n=4 Participants	63.0 Years STANDARD_DEVIATION 5.3 • n=21 Participants	56.7 Years STANDARD_DEVIATION 15.4 • n=10 Participants	66.5 Years STANDARD_DEVIATION 9.9 • n=115 Participants	73.3 Years STANDARD_DEVIATION 6.7 • n=24 Participants	60.4 Years STANDARD_DEVIATION 10.2 • n=42 Participants	65.5 Years STANDARD_DEVIATION 10.3 • n=42 Participants	58.7 Years STANDARD_DEVIATION 6.2 • n=42 Participants	64.42 Years STANDARD_DEVIATION 9.94 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	4 Participants n=24 Participants	9 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	37 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=24 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	25 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants	5 Participants n=24 Participants	12 Participants n=42 Participants	8 Participants n=42 Participants	9 Participants n=42 Participants	58 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants	6 Participants n=24 Participants	13 Participants n=42 Participants	8 Participants n=42 Participants	9 Participants n=42 Participants	58 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.

Population: MTD Evaluation Set (Part A): All patients who received BI 891065 and completed the safety assessments required during cycle 1 or who experienced a DLT during cycle 1.

Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being above 33% during the MTD evaluation period.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=21 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part A - Maximum Tolerated Dose (MTD) of BI 891065	NA Milligram The MTD has not been reached and identified in Part A of this study because of the low number of dose limiting toxicities (DLTs) observed.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.

Population: MTD Evaluation Set (Part A): All patients who received BI 891065 and completed the safety assessments required during cycle 1 or who experienced a DLT during cycle 1.

DLT is defined as: Hematologic toxicities for patients with solid tumors: Any Grade 5 toxicity; Neutropenia ≥Grade 4 lasting for \>5 days; Febrile neutropenia of any duration; Neutropenia Grade 3 with documented infection; Grade thrombocytopenia 4, or Grade 3 with bleeding or require platelet transfusion; Grade 4 anemia unexplained by underlying disease. Non-hematological toxicities: AST or ALT \>3xULN and concurrent total bilirubin \>2xULN without initial findings of cholestasis; ≥Grade 4 AST or ALT; Any ≥Grade 3 non-hematologic toxicity with some exceptions listed in protocol; Any Grade 2 pneumonitis; Any Grade 2 related uveitis, eye pain, or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within 2 weeks or requires systemic treatment; Any treatment-related ≥Grade 2 toxicity that persists and results in an inability to administer BI 754091 on Cycle 2 Day 1.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=2 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=2 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=4 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 n=3 Participants 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 Participants 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=6 Participants 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part A - Number of Patients With Dose-limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.

Population: MTD Evaluation Set (Part B): All patients who received BI 891065 and BI 754091, and completed the safety assessments required during cycle 1 or who experienced a DLT during cycle 1.

Maximum tolerated dose (MTD) of BI 891065 in combination with ezabenlimab, defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being above 33% during the MTD evaluation period.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=31 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Maximum Tolerated Dose (MTD) of BI 891065 in Combination With Ezabenlimab	NA Milligram The MTD has not been reached and identified in Part A of this study because of the low number of dose limiting toxicities (DLTs) observed.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: First treatment cycle (MTD evaluation period), up to 21 days.

Population: MTD Evaluation Set (Part B): All patients who received BI 891065 and BI 754091, and completed the safety assessments required during cycle 1 or who experienced a DLT during cycle 1.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=6 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=13 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=5 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=7 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Number of Patients With Dose-limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From first drug administration until last drug administration plus residual effect period of 30 days, up to 282 days.

Population: Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least 1 dose of BI 891065.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=3 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=4 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 n=3 Participants 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 Participants 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=8 Participants 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part A: Number of Patients With Dose-limiting Toxicities (DLT) During the Entire On-treatment Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 252 days.

Population: Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least 1 dose of BI 891065.

OR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, defined as the best overall response of complete response (CR) and partial response (PR), where the best overall response is the best time point response recorded from the first administration of study medication until the end of treatment Number of patients with objective response is reported.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=3 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=4 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 n=3 Participants 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 Participants 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=8 Participants 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part A: Number of Patients With Objective Response (OR) No	3 Participants	1 Participants	3 Participants	4 Participants	3 Participants	3 Participants	8 Participants
Part A: Number of Patients With Objective Response (OR) Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Just before drug intake and 0.5**, 1, 2, 3, 4*, 5, 6, 7, 8, 10**, 12*, 24, 36, 47.917, 167.917, 263.917, 335.917, 336.5**, 337, 338, 339, 340*, 341, 342, 343, 344, 346**, 348*, 359.917 hours after drug administration on day 1.

Population: Pharmacokinetic Parameter Set (PKS) (Part A): All patients in the TS (Part A) who have at least one valid secondary pharmacokinetic (PK) endpoint available. Only patients with available data for this endpoint were analyzed.

Maximum measured plasma concentration at steady state (cmax,ss) during the first treatment cycle. Timeframe description: \*: Timepoint measured only for dose group 5 mg, 15 mg, 25 mg, and 50 mg. \*\*: Timepoint measured only for dose group 50 mg, 100 mg, 200 mg and 400 mg.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=2 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=4 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 n=3 Participants 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 Participants 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=6 Participants 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part A: Maximum Measured Plasma Concentration of BI 891065 at Steady State (Cmax,ss)	86.3 nanomol per Liter (nmol/L) Geometric Coefficient of Variation 39.6	163 nanomol per Liter (nmol/L) Geometric Coefficient of Variation NA Since only 1 patient was analyzed no geometric coefficient of variation is available.	948 nanomol per Liter (nmol/L) Geometric Coefficient of Variation 61.5	708 nanomol per Liter (nmol/L) Geometric Coefficient of Variation 123	1410 nanomol per Liter (nmol/L) Geometric Coefficient of Variation 56.0	3070 nanomol per Liter (nmol/L) Geometric Coefficient of Variation 88.3	2550 nanomol per Liter (nmol/L) Geometric Coefficient of Variation 68.5

SECONDARY outcome

Area under the concentration time curve of BI 891065 over a dosing interval at steady state (AUCtau,ss). Timeframe description: \*: Timepoint measured only for dose group 5 mg, 15 mg, 25 mg, and 50 mg. \*\*: Timepoint measured only for dose group 50 mg, 100 mg, 200 mg and 400 mg.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=2 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=2 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=4 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 n=3 Participants 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 Participants 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=5 Participants 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part A: Area Under the Concentration Time Curve of BI 891065 Over a Dosing Interval at Steady State (AUCtau,ss)	713 Nanomol * hours per Liter Geometric Coefficient of Variation 33.8	2070 Nanomol * hours per Liter Geometric Coefficient of Variation NA Since only 1 patient was analyzed no geometric coefficient of variation is available.	10600 Nanomol * hours per Liter Geometric Coefficient of Variation 190	10700 Nanomol * hours per Liter Geometric Coefficient of Variation 91.5	18800 Nanomol * hours per Liter Geometric Coefficient of Variation 72.2	51300 Nanomol * hours per Liter Geometric Coefficient of Variation 87.5	48500 Nanomol * hours per Liter Geometric Coefficient of Variation 57.5

SECONDARY outcome

Population: Pharmacokinetic Parameter Set (PKS) (Part A): All patients in the TS (Part A) who have at least one valid secondary pharmacokinetic (PK) endpoint available.

Area under the concentration-time curve of BI 891065 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in the first treatment cycle. Timeframe description: \*: Timepoint measured only for dose group 5 mg, 15 mg, 25 mg, and 50 mg. \*\*: Timepoint measured only for dose group 50 mg, 100 mg, 200 mg and 400 mg.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=3 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=4 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 n=3 Participants 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 Participants 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=8 Participants 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part A: Area Under the Concentration-time Curve of BI 891065 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	281 Nanomol * hours per Liter Geometric Coefficient of Variation 44.6	1930 Nanomol * hours per Liter Geometric Coefficient of Variation NA Since only 1 patient was analyzed no geometric coefficient of variation is available.	5030 Nanomol * hours per Liter Geometric Coefficient of Variation 113	5820 Nanomol * hours per Liter Geometric Coefficient of Variation 38.8	12900 Nanomol * hours per Liter Geometric Coefficient of Variation 73.5	25200 Nanomol * hours per Liter Geometric Coefficient of Variation 8.49	35800 Nanomol * hours per Liter Geometric Coefficient of Variation 51.0

SECONDARY outcome

Timeframe: From first drug administration until last drug administration plus residual effect period of 30 days, up to 386 days.

Population: Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=6 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=14 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=8 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=9 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Number of Patients With Dose-limiting Toxicities (DLTs) Observed During the Entire Treatment Period	0 Participants	1 Participants	1 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 356 days.

Population: Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.

OR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, defined as the best overall response of complete response (CR) and partial response (PR), where the best overall response is the best time point response recorded from the first administration of study medication until the end of treatment. Number of patients with objective response is reported.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=6 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=14 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=8 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=9 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Number of Patients With Objective Response (OR) No	6 Participants	14 Participants	8 Participants	9 Participants	—	—	—
Part B: Number of Patients With Objective Response (OR) Yes	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: At 1.417, 2, 2.5, 3.5, 4.5, 6.5, 7.5, 8.5, 9.5, 11.5, 25.417, 167.917, 263.917, 335.917, 336.5, 337, 338, 339, 341, 342, 343, 344, 346, 359.5, 360.5, 361, 362, 363, 365, 366, 367, 368, 370 and 383.917 hours after intake of BI 891065 at day 1, cycle 1.

Population: Pharmacokinetic Parameter Set (PKS) (Part B): All patients in the TS (Part B) who have at least one valid secondary pharmacokinetic (PK) endpoint available.

Area under the concentration-time curve of BI 891065 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in the first treatment cycle.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=6 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=14 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=8 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=9 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Area Under the Concentration-time Curve of BI 891065 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	3450 Hours*nanomol / Liter Geometric Coefficient of Variation 44.4	17200 Hours*nanomol / Liter Geometric Coefficient of Variation 82.9	31400 Hours*nanomol / Liter Geometric Coefficient of Variation 56.5	20300 Hours*nanomol / Liter Geometric Coefficient of Variation 71.6	—	—	—

SECONDARY outcome

Population: Pharmacokinetic Parameter Set (PKS) (Part B): All patients in the TS (Part B) who have at least one valid secondary pharmacokinetic (PK) endpoint available. Only patients with available data for this endpoint were analyzed.

Area under the concentration time curve of BI 891065 over a dosing interval at steady state (AUCtau,ss) in the first treatment cycle.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=5 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=9 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=6 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Area Under the Concentration Time Curve of BI 891065 Over a Dosing Interval at Steady State (AUCtau,ss)	7260 Hours*nanomol/Liter Geometric Coefficient of Variation 91.0	50600 Hours*nanomol/Liter Geometric Coefficient of Variation 78.0	44000 Hours*nanomol/Liter Geometric Coefficient of Variation 49.1	34400 Hours*nanomol/Liter Geometric Coefficient of Variation 88.0	—	—	—

SECONDARY outcome

Maximum measured plasma concentration of BI 891065 at steady state (Cmax,ss) in the first treatment cycle.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=5 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=9 Participants 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 n=3 Participants 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 n=6 Participants 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Maximum Measured Plasma Concentration of BI 891065 at Steady State (Cmax,ss)	623 Nanomol/Liter Geometric Coefficient of Variation 77.0	3010 Nanomol/Liter Geometric Coefficient of Variation 67.8	3220 Nanomol/Liter Geometric Coefficient of Variation 33.4	3460 Nanomol/Liter Geometric Coefficient of Variation 79.5	—	—	—

SECONDARY outcome

Timeframe: Predose and 1, 1.417, 2, 2.5, 3.5, 4.5, 6.5, 7.5, 8.5, 9.5, 11.5, 25.417, 167.917, 263.917, 335.917, 359.5, 383.917, 504, 998 and 999 hours after intake of BI 754091 at day 1, cycle 1.

Population: Pharmacokinetic Parameter Set (PKS) (Part B): All patients in the TS (Part B) who have at least one valid secondary pharmacokinetic (PK) endpoint available. As pre-specified in the protocol, the four cohorts in Part B were treated with the same dosage of BI 754091 and analyzed together.

Maximum measured plasma concentration (Cmax) of BI 754091 in the first treatment cycle. Results are reported for the overall group only since dose level of BI 754091 is fixed in this trial.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=37 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Maximum Measured Plasma Concentration (Cmax) of BI 754091 in the First Treatment Cycle	79.7 Microgram/milliliter Geometric Coefficient of Variation 22.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose and 1, 1.417, 2, 2.5, 3.5, 4.5, 6.5, 7.5, 8.5, 9.5, 11.5, 25.417, 167.917, 263.917, 335.917, 359.5, 383.917, 504, 998 and 999 hours after intake of BI 754091 at day 1, cycle 1.

Area under the concentration-time curve of BI 754091 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in the first treatment cycle. Results are reported for the overall group only since dose level of BI 754091 is fixed in this trial.

Outcome measures

Outcome measures
Measure	Part A: BI 891065 n=37 Participants Film-coated tablets of BI 891065 (dose level 5 mg, 15 mg, 25 mg, 50 mg, 100 mg, 200 mg or 400 mg) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 25 mg BI 891065 1 film-coated tablet of 5 mg plus 1 film-coated tablet of 20 mg (25 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 50 mg BI 891065 1 film-coated tablet of 50 mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 100 mg BI 891065 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.
Part B: Area Under the Concentration-time Curve of BI 754091 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	13100 Hours*micorgram/milliliter Geometric Coefficient of Variation 48.7	—	—	—	—	—	—

Adverse Events

Part A: 5 mg BI 891065

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Part A: 15 mg BI 891065

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Part A: BI 891065 25 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A: BI 891065 50 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Part A: 100 mg BI 891065

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A: 200 mg BI 891065

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Part A: 400 mg BI 891065

Serious events: 2 serious events

Other events: 8 other events

Deaths: 2 deaths

Part B: 50 mg BI 891065 QD + 240 mg BI 754091

Serious events: 0 serious events

Other events: 6 other events

Deaths: 2 deaths

Part B: 200 mg BI 891065 QD + 240 mg BI 754091

Serious events: 3 serious events

Other events: 13 other events

Deaths: 2 deaths

Part B: 400 mg BI 891065 QD + 240 mg BI 754091

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Part B: 200 mg BI 891065 BID + 240 mg BI 754091

Serious events: 2 serious events

Other events: 9 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Part A: 5 mg BI 891065 n=3 participants at risk 1 film-coated tablet of 5 milligram (mg) of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 participants at risk 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: BI 891065 25 mg n=3 participants at risk 1 film-coated tablet of 5mg plus 1 film-coated tablet of 20mg (25mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part A: BI 891065 50 mg n=4 participants at risk 1 film-coated tablet of 50mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part A: 100 mg BI 891065 n=3 participants at risk 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 participants at risk 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=8 participants at risk 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part B: 50 mg BI 891065 QD + 240 mg BI 754091 n=6 participants at risk 1 film-coated tablet of 50mg of BI 891065 was administered orally once daily (QD) in combination with 240 milliliter (mL) solution for infusion after dilution of BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 QD + 240 mg BI 754091 n=14 participants at risk 4 film-coated tablets of 50 mg, or 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 400 mg BI 891065 QD + 240 mg BI 754091 n=8 participants at risk 4 film-coated tablets of 100 mg (400 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 BID + 240 mg BI 754091 n=9 participants at risk 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally twice daily (BID) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.
Cardiac disorders Angina pectoris	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Fatigue	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Oedema peripheral	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Sepsis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Septic shock	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Psychiatric disorders Confusional state	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Psychiatric disorders Delirium	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Psychiatric disorders Mental status changes	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Renal and urinary disorders Renal failure	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.

Other adverse events

Other adverse events
Measure	Part A: 5 mg BI 891065 n=3 participants at risk 1 film-coated tablet of 5 milligram (mg) of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 15 mg BI 891065 n=1 participants at risk 3 film-coated tablets of 5 mg (15 mg total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: BI 891065 25 mg n=3 participants at risk 1 film-coated tablet of 5mg plus 1 film-coated tablet of 20mg (25mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part A: BI 891065 50 mg n=4 participants at risk 1 film-coated tablet of 50mg of BI 891065 was administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as they derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part A: 100 mg BI 891065 n=3 participants at risk 2 film-coated tablets of 50 mg (100 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 200 mg BI 891065 n=3 participants at risk 4 film-coated tablets of 50 mg of BI 891065 (200 mg in total) were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part A: 400 mg BI 891065 n=8 participants at risk 8 film-coated tablets of 50 mg (400 mg in total) of BI 891065 were administered orally once daily in patients with advanced and/or metastatic malignancies. Treatment cycles were 21 days. Patients continued treatment with BI 891065 as long as the derived clinical benefit. (Up to 252 days). Patients were asked to fast overnight, at least 10 hours prior to day 1 and day 15 in cycle 1.	Part B: 50 mg BI 891065 QD + 240 mg BI 754091 n=6 participants at risk 1 film-coated tablet of 50mg of BI 891065 was administered orally once daily (QD) in combination with 240 milliliter (mL) solution for infusion after dilution of BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 QD + 240 mg BI 754091 n=14 participants at risk 4 film-coated tablets of 50 mg, or 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 400 mg BI 891065 QD + 240 mg BI 754091 n=8 participants at risk 4 film-coated tablets of 100 mg (400 mg total) of BI 891065 were administered orally once daily (QD) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.	Part B: 200 mg BI 891065 BID + 240 mg BI 754091 n=9 participants at risk 2 film-coated tablets of 100 mg (200 mg total) of BI 891065 were administered orally twice daily (BID) in combination with 240 mg BI 754091, administered as intravenous infusion, on day 1 of each treatment cycle. Treatment cycles were 21 days. Patients were allowed to continue treatment with BI 891065 and BI 754091 as long as they derived clinical benefit. (Up to 356 days). Patients were asked to fast overnight, at least 10 hours prior to day 1, day 15 and day 16 in cycle 1.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Cardiac disorders Bradycardia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	14.3% 2/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Eye disorders Lacrimation increased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Eye disorders Periorbital swelling	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Eye disorders Vision blurred	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Ascites	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	14.3% 2/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Colitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Constipation	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	100.0% 1/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 2/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	28.6% 4/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Nausea	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 2/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	62.5% 5/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 3/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	87.5% 7/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 3/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Toothache	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	14.3% 2/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	62.5% 5/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 3/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Asthenia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Chills	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	44.4% 4/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Early satiety	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Facial pain	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Fatigue	100.0% 3/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 2/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	35.7% 5/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	87.5% 7/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	77.8% 7/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Gait disturbance	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Influenza like illness	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Malaise	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Mucosal inflammation	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Non-cardiac chest pain	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Oedema peripheral	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Pyrexia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	55.6% 5/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
General disorders Swelling	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Hepatobiliary disorders Hepatitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Bacterial infection	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Candida infection	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	14.3% 2/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 3/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Conjunctivitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Escherichia urinary tract infection	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Herpes zoster	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Localised infection	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Oral candidiasis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Otitis media	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Rash pustular	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Rhinitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Sinusitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Infections and infestations Urinary tract infection	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	66.7% 4/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 2/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Blood bilirubin increased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 4/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 7/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	55.6% 5/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Blood creatinine increased	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	14.3% 2/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Blood potassium decreased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations International normalised ratio increased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Neutrophil count decreased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Platelet count decreased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Weight decreased	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Investigations Weight increased	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 3/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	14.3% 2/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 3/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	44.4% 4/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hyperkalaemia	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Nervous system disorders Amnesia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Nervous system disorders Dizziness	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 3/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Nervous system disorders Dysgeusia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Nervous system disorders Headache	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Nervous system disorders Presyncope	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Nervous system disorders Syncope	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Psychiatric disorders Anxiety	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Psychiatric disorders Confusional state	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Psychiatric disorders Depression	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Psychiatric disorders Insomnia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Renal and urinary disorders Dysuria	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Renal and urinary disorders Haematuria	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Renal and urinary disorders Micturition urgency	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	100.0% 1/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	50.0% 2/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 1/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	7.1% 1/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	22.2% 2/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	14.3% 2/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	37.5% 3/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	21.4% 3/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	12.5% 1/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	33.3% 3/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Vascular disorders Hypertension	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Vascular disorders Hypotension	33.3% 1/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	25.0% 2/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.
Vascular disorders Phlebitis	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/1 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/4 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/3 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	16.7% 1/6 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/14 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	0.00% 0/8 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.	11.1% 1/9 • Part A: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 282 days. Part B: From first drug administration until last drug administration plus 30 days residual effect period (REP), up to 386. Number of deaths differ compared to number in participant flow, due to different timeframe. Treated Set (TS) (Part A): The TS (Part A) included all patients who received at least one dose of BI 891065. Treated Set (TS) (Part B): The TS (Part B) included all patients who received at least one dose of BI 891065 or BI 754091.

Additional Information

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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.
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